StemCell Therapy

Overview

Chronic obstructive pulmonary disease (COPD) is a progressive, degenerative lung disease resulting from a long-term inflammatory response to inhaled irritants. As the inflammatory process continues, the small airways narrow, inhibiting airflow; and healthy lung tissue is broken down, preventing appropriate absorption of oxygen. Due to these disease processes, the ability to breathe becomes increasingly difficult. Eventually, even simple tasks and short bursts of activity can heavily strain an individuals stamina. The result is a substantially reduced quality of life for an individual with COPD.

There are 2 main types of COPD:

Emphysema

is a common type of COPD in which the air sacs of the lungs become damaged, causing them to enlarge and burst. Damage in this area makes it difficult for people with emphysema to expel air from their lungs.

Chronic Bronchitis

causes inflammation and irritation of the airways, the tubes in your lungs where air passes through. When the air tubes are inflamed and irritated, thick mucus begins to form in them. Over time, this mucus plugs up airways and makes breathing difficult.

Although there is no cure for the disease, many patients can experience a significant reduction in the severity of their symptoms through stem cell therapy for COPD. With a stem cell transplant for COPD to targeted areas in the lungs and airway, the progression of the disease can be slowed and the patients quality of life can be improved by the lessening of the diseases symptoms and complications. By focusing treatment on the specific areas of the respiratory system that are affected by the disease, stem cell therapy has the potential to make life easier for patients who have COPD. TruStem Cell Therapy has the potential to relieve multiple complications related to COPD, such as reduced stamina, decreased mobility, shortness of breath and respiratory infections.

Symptoms/Complications

Increased breathlessness

Frequent coughing (with and without sputum)

Wheezing

Tightness in chest

Reliance on supplementary oxygen

Causes

Smoking

About 85 to 90 percent of all COPD cases are caused by cigarette smoking. When a cigarette burns, it creates more than 7,000 chemicals, many of which are harmful. The toxins in cigarette smoke weaken your lungs defense against infections, narrow air passages, cause swelling in air tubes and destroy air sacsall contributing factors for COPD.

Environment

What you breathe every day at work, home and outside can play a role in developing COPD. Long-term exposure to air pollution, secondhand smoke and dust, fumes and chemicals (which are often work-related) can cause COPD.

Genetic

A small number of people have a rare form of COPD called alpha-1 deficiency-related emphysema. This form of COPD is caused by a genetic (inherited) condition that affects the bodys ability to produce a protein (Alpha-1) that protects the lungs.

TruStem Cell Therapy

TruStem Cell Therapy provides access to treatment that utilizes a patients stem cells isolated from his or her own fat tissue. There are multiple inherent benefits afforded by the utilization of adipose derived stem cells including their ability to differentiate into a broad variety of cell types (neurons, bone, cartilage, muscle, tendon, etc.), they are present at comparatively much higher levels than other stem cell types, possess higher immunomodulatory capacity, and they do not endanger a patients health the way other stem cells might.

Approximately 150-250ccs of a patients own fat tissue is harvested through a minimally invasive, mini liposuction procedure. Generally, this fat tissue is collected from around the patients belly region.

Adipose tissue is preferentially utilized because it is one of the richest, most accessible sources of stem cells in the human body.

Harvested fat tissue is immediately taken to the onsite laboratory for processing. At this step, an optimized protocol is used to isolate the maximum number of stem cells from collected fat tissue.

Stem cell activation is part of what makes TruStem Cell Therapy unique. The activation procedure is designed to augment efficacy.

TruStem Cell Therapy utilizes both systematic and novel administration methods to fully saturate the body with stem cells while targeting specific areas of injury.

COPD patients who receive stem cell therapy through us can receive multiple systemic and targeted administration methods:

Systemic IV infusion of their stem cells to fully saturate the entire body.

Stem cells are delivered via a nebulizer for distribution throughout and deep into the lungs as the patients breathe in the stem cells.

Our focus is safety, efficacy, and patient-centric care when providing access to superior stem cell therapy.

We utilize only board-certified surgeons, physicians and accredited clinicians to provide care for patients.

Laboratory protocols are developed and refined by our PhD Neuroscientist.

A clinical team with expertise in practicing cellular based medicine.

Accredited Surgical Centers for enhanced procedural and patient safety

Skilled Patient Advocates who are trained to provide truthful, realistic expectations resulting from stem cell therapy. We do not make outlandish promises of cures or inaccurate claims related to improvement rates.

FAQ

It is important for patients and caregivers to understand that current therapies, including stem cell treatment, do not provide a cure for COPD. However, TruStem Cell Therapy does have the potential to improve a patients quality of life by reducing symptoms and complications related to COPD as well as slowing its progression.

The FDA has not approved stem cell therapy for COPD. As noted above, studies have demonstrated the safety and efficacy of stem cell therapy for this condition but additional studies are needed before FDA approval can be secured.

It is possible through these treatments, to improve a patients quality of lifebyminimizing disease-relatedsymptoms and complications. For COPD patients, it is possible to see improvements in any one ormultipledisease-related complications such as: supplemental oxygen consumption, stamina, mobility, fatigue, respiratory infections, shortness of breath, etc. If you have questions regarding how these treatments may help you, please contact one of our Patient Advocates to learn more.

It is difficult to predict the timeline of a patients response. Every patient responds differently to treatment. It could take weeks to months for the stem cells to provide noticeable results.

Typically patients will experience some level of soreness and bruising lasting roughly a week as a result of the mini-liposuction procedure. Additional complications have not been observed. Over a hundred studies and clinical trials have demonstrated the safety and minimal side-effect profile of stem cell therapy.

Excerpt from:
Stem Cell Treatment & Therapy for COPD | Pulmonary Disease

Adipose Derived Stem Cells:

Adipose derived stem cells are obtained from a sample of human abdominal fat tissue. The cells themselves are not fat. They are encased in and surrounded by fat tissue.Once the fat sample has been obtained, a special enzyme is used to melt-away the fat, and leave only something called SVF (short for Stromal Vascular Fraction), which contains stem cells, accessory cells and growth factors.

This SVF is washed and purified in the lab, and is then isolated for infusion or injection.

This method provides a much larger number of stem cells than bone marrow or peripheral blood, making it more efficient and highly effective in a variety of conditions, especially those that require creation of new blood vessels, and repairing tissues damaged due to lack of oxygenation.

Whartons Jelly Derived Stem cells:

Unlike Fat, Bone marrow or other tissues that can be harvested for stem cell isolation, Whartons Jelly does not contain SVF. It is a gelatinous substance found in the umbilical chord, which separates maternal and fetal tissues, acting as a kind of buffer so that these tissues dont come into direct contact with each other. This particular characteristic is the reason they became known as universal donor cells, since they are able to interact with any tissue, in any host, without causing any form of immune response.

Unlike cells obtained with SVF, stem cells in Whartons jelly are not found grouped with other cells types or blood products. They can be obtained in much larger numbers, and are already completely isolated, which means that you get stem cells exclusively.

The fact that they are obtained from umbilical chords, donated by pre-screened donors after their pregnancy has come to full-term, means that they are much easier to harvest, in much larger numbers, and without the need for a specific, invasive and painful procedure. It also means that because of the incredibly large number of cells that can be obtained, they can be cryo-preserved and stored at pre-determined dose sizes in individual containers for specific uses.

Excerpt from:
Stem Cell Therapy in Mexico - Official Treatment Center

Stem Cell Therapy for Parkinsons Disease

Today, new treatments and advances in research are giving new hope to people affected by Parkinsons Disease. StemGenexStem Cell Research Centre provides Parkinsons stem cell therapy to help those with unmet clinical needs achieve optimum health and better quality of life. A clinical study registered through the National Institutes of Health (NIH) atwww.clinicaltrials.gov/stemgenex has been established to evaluate the quality of life changes in individuals with Parkinsons Disease following stem cell therapy.

Parkinsons Disease stem cell therapy is being studied for efficacy in improving the complications in patients through the use of their own stem cells.These procedures may help patients who dont respond to typical drug treatment, want to reduce their reliance on medication, or are looking to try stem cell therapy before starting drug treatment for Parkinsons.

To learn more about becoming a patient and receiving stem cell therapy through StemGenex Stem Cell Research Centre, please contact one of our Patient Advocates at (800) 609-7795. Below are some frequently asked questions aboutstem cell therapy for Parkinsons Disease.

The majority of complications in Parkinsons patients are related to the failure of dopamine neurons to do their job properly. Dopamine sends signals to the part of your brain that controls movement. It lets your muscles move smoothly and do what you want them to do. Once the nerve cells break down you no longer have enough dopamine, and you have trouble moving and completing tasks.

This stem cell treatment for Parkinson's disease is designed to target these neurons and to help with the creation of new dopamine producing neurons. In addition, stem cells may release natural chemicals called cytokines which can induce differentiation of the stem cells into dopamine producing neurons.

Upholding the highest levels of ethical conduct, safety and efficacy is our primary focus. Five clinical stem cell studies for Parkinson's Disease, Multiple Sclerosis, Osteoarthritis, Rheumatoid Arthritis and Chronic Obstructive Pulmonary Disease (COPD) are registered through the National Institutes of Health (NIH) at http://www.clinicaltrials.gov/stemgenex. Each clinical study is reviewed and approved by an independent Institutional Review Board (IRB) to ensure proper oversight and protocols are being followed.

Stem cells are the basic building blocks of human tissue and have the ability to repair, rebuild, and rejuvenate tissues in the body. When a disease or injury strikes, stem cells respond to specific signals and set about to facilitate the healing process by differentiating into specialized cells required for the bodys repair.

There are four known types of stem cells which include:

StemGenex provides autologous adult stem cells (from fat tissue) where the stem cells come from the person receiving treatment.

StemGenex provides autologous adult adipose-derived stem cells (from fat tissue) where the stem cells come from the person receiving treatment.

We tap into our bodys stem cell reserve daily to repair and replace damaged or diseased tissue. When the bodys reserve is limited and as it becomes depleted, the regenerative power of our body decreases and we succumb to disease and injury.

Three sources of stem cells from a patients body are used clinically which include adipose tissue (fat), bone marrow and peripheral blood.

Performed by Board Certified Physicians, dormant stem cells are extracted from the patients adipose tissue (fat) through a minimally invasive mini-liposuction procedure with little to no downtime.

During the liposuction procedure, a small area (typically the abdomen) is numbed with an anesthetic and patients receive mild to moderate sedation. Next, the extracted dormant stem cells are isolated from the fat and activated, and then comfortably infused back into the patient intravenously (IV) and via other directly targeted methods of administration. The out-patient procedure takes approximately four to five hours.

StemGenex provides multiple administration methods for Parkinson's Disease patients to best target the disease related conditions and symptoms which include:

Since each condition and patient are unique, there is no guarantee of what results will be achieved or how quickly they may be observed. According to patient feedback, many patients report results in one to three months, however, it may take as long as six to nine months. Individuals interested in stem cell therapy are urged to consult with their physician before choosing investigational autologous adipose-derived stem cell therapy as a treatment option.

In order to determine if you are a good candidate for adult stem cell treatment, you will need to complete a medical history form which will be provided by your StemGenex Patient Advocate. Once you complete and submit your medical history form, our medical team will review your records and determine if you are a qualified candidate for adult stem cell therapy.

StemGenex team members are here to help assist and guide you through the patient process.

Patients travel to StemGenex located in Del Mar, California located in San Diego County for stem cell treatment from all over the United States, Canada and around the globe. Treatment will consist of one visit lasting a total of three days. The therapy is minimally invasive and there is little to no down time. Majority of patients fly home the day after treatment.

We provide stem cell therapy for a wide variety of diseases and conditions for which traditional treatment offers less than optimal options. Some conditions include Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Osteoarthritis and Chronic Obstructive Pulmonary Disease (COPD).

The side effects of the mini-liposuction procedure are minimal and may include but are not limited to: minor swelling, bruising and redness at the procedure site, minor fever, headache, or nausea. However, these side effects typically last no longer than 24 hours and are experienced mostly by people with sensitivity to mild anesthesia. No long-term negative side effects or risks have been reported.

The side effects of adipose-derived stem cell therapy are minimal and may include but are not limited to: infection, minor bleeding at the treatment sites and localized pain. However, these side effects typically last no longer than 24 hours. No long-term negative side effects or risks have been reported.

StemGenex provides adult stem cell treatment with mesenchymal stem cells which come from the person receiving treatment. Embryonic stem cells are typically associated with ethical and political controversies.

The FDA is currently in the process of defining a regulatory path for cellular therapies. A Scientific Workshop and Public Hearing Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products was held in September 2016 at the National Institutes of Health (NIH) in Bethesda, MD. Currently, stem cell treatment is not FDA approved.

In March 2016, bipartisan legislation, the REGROW Act was introduced to the Senate and House of Representatives to develop and advance stem cell therapies.

Stem cell treatment is not covered by health insurance at this time. The cost for standard preoperative labs are included. Additional specific labs may be requested at the patients expense.

People suffering from Parkinson's Disease often suffer from the following complications::

Link:
Parkinson's Stem Cell Treatment | Parkinson's Disease Story

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Petryk A, Bergemann TL, Polga KM, Ulrich KJ, Raatz SK, Brown DM. Prospective study of changes in bone mineral density and turnover in children after hematopoietic cell transplantation. J Clin Endocrinol Metab. 2006 Mar. 91(3):899-905. [Medline].

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de Kleijn MJ, van der Schouw YT, Verbeek AL, Peeters PH, Banga JD, van der Graaf Y. Endogenous estrogen exposure and cardiovascular mortality risk in postmenopausal women. Am J Epidemiol. 2002 Feb 15. 155(4):339-45. [Medline].

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Yao S, McCarthy PL, Dunford LM, Roy DM, Brown K, Paplham P. High prevalence of early-onset osteopenia/osteoporosis after allogeneic stem cell transplantation and improvement after bisphosphonate therapy. Bone Marrow Transplant. 2008 Feb. 41(4):393-8. [Medline].

Salooja N, Szydlo RM, Socie G, Rio B, Chatterjee R, Ljungman P. Pregnancy outcomes after peripheral blood or bone marrow transplantation: a retrospective survey. Lancet. 2001 Jul 28. 358(9278):271-6. [Medline].

Winther JF, Boice JD Jr, Frederiksen K, Bautz A, Mulvihill JJ, Stovall M. Radiotherapy for childhood cancer and risk for congenital malformations in offspring: a population-based cohort study. Clin Genet. 2009 Jan. 75(1):50-6. [Medline]. [Full Text].

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Bakker B, Massa GG, Oostdijk W, Van Weel-Sipman MH, Vossen JM, Wit JM. Pubertal development and growth after total-body irradiation and bone marrow transplantation for haematological malignancies. Eur J Pediatr. 2000 Jan-Feb. 159(1-2):31-7. [Medline].

Somali M, Mpatakoias V, Avramides A, Sakellari I, Kaloyannidis P, Smias C. Function of the hypothalamic-pituitary-gonadal axis in long-term survivors of hematopoietic stem cell transplantation for hematological diseases. Gynecol Endocrinol. 2005 Jul. 21(1):18-26. [Medline].

Anserini P, Chiodi S, Spinelli S, Costa M, Conte N, Copello F. Semen analysis following allogeneic bone marrow transplantation. Additional data for evidence-based counselling. Bone Marrow Transplant. 2002 Oct. 30(7):447-51. [Medline].

Sanders JE, Hawley J, Levy W, Gooley T, Buckner CD, Deeg HJ. Pregnancies following high-dose cyclophosphamide with or without high-dose busulfan or total-body irradiation and bone marrow transplantation. Blood. 1996 Apr 1. 87(7):3045-52. [Medline].

Sanders JE, Hoffmeister PA, Woolfrey AE, Carpenter PA, Storer BE, Storb RF. Thyroid function following hematopoietic cell transplantation in children: 30 years'' experience. Blood. 2009 Jan 8. 113(2):306-8. [Medline]. [Full Text].

Cohen A, Rovelli A, Merlo DF, van Lint MT, Lanino E, Bresters D. Risk for secondary thyroid carcinoma after hematopoietic stem-cell transplantation: an EBMT Late Effects Working Party Study. J Clin Oncol. 2007 Jun 10. 25(17):2449-54. [Medline].

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Faraci M, Barra S, Cohen A, Lanino E, Grisolia F, Miano M. Very late nonfatal consequences of fractionated TBI in children undergoing bone marrow transplant. Int J Radiat Oncol Biol Phys. 2005 Dec 1. 63(5):1568-75. [Medline].

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Patriarca F, Skert C, Bonifazi F, Sperotto A, Fili C, Stanzani M. Effect on survival of the development of late-onset non-infectious pulmonary complications after stem cell transplantation. Haematologica. 2006 Sep. 91(9):1268-72. [Medline].

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Soci G, Salooja N, Cohen A, Rovelli A, Carreras E, Locasciulli A. Nonmalignant late effects after allogeneic stem cell transplantation. Blood. 2003 May 1. 101(9):3373-85. [Medline].

Original post:
Long-Term Effects of Bone Marrow Transplantation: Overview ...

Following hematopoietic cell transplantation (HCT), recipients will be immunocompromised and may also have treatment-related organ and tissue damage. Transplant recipients therefore require careful monitoring in the early post-transplant period to ensure that complications are recognized early, while there are more therapeutic options and while treatments can be more effective.

Better clinical care and management of early post-transplant complications have led to significantly lower rates of transplant-related mortality (TRM) over time. Figure 1 shows that one-year TRM has become significantly lower over time for unrelated donor transplants in adults with leukemia, lymphoma, myeloproliferative neoplasms, and myelodysplastic syndromes (pointwise p-value at all time points <0.001). [1]

Download slide: Transplant-Related Mortality after Adult Bone Marrow or PBSC Transplantation for Malignant Diseases

The most common complications that may occur in the early post-transplant period from transplant infusion to one year post-transplant are listed below. Recognizing marrow transplant complications early is critical to the health of transplant recipients, and a timely collaboration with the transplant center to develop a treatment plan is recommended.

Because it is a complex disease with many manifestations, chronic graft-versus-host disease (GVHD) is discussed separately.

Oral Mucositis

Oral mucositis is inflammation of oral mucosa that typically manifests as erythema or ulcerations. It can result from the cytotoxic effects of chemotherapy- and radiation-based pre-transplant conditioning regimens. [2,3]

Mouth sores associated with acute graft-versus-host disease (GVHD) may also develop 2-4 weeks post-transplant. The severity and the patient's hematologic status govern appropriate oral management. Meticulous oral hygiene and palliation of symptoms are essential.

Acute Graft-Versus-Host Disease (GVHD)

Acute GVHD is a common complication of allogeneic transplantation in which activated donor T cells attack the tissues of the transplant recipient after recognizing host tissues as antigenically foreign. The resulting inflammatory cytokines can cause tissue damage, and the commonly involved organs include the liver, skin, mucosa, and the gastrointestinal tract.

By classical definition, GVHD appearing before day 100 post-transplant is acute GVHD, and GVHD appearing after day 100 is chronic GVHD. However, acute GVHD may still occur later than 100 days post transplant (e.g., during tapering of immunosupressive drugs, or following a donor lymphocyte infusion). Some patients may also develop an overlap syndrome, where features of both acute and chronic GVHD are present. [4,5]

Stem Cell Graft Failure

Graft failure is a rare, but life-threatening complication following allogeneic HCT. The most common cause of graft failure is an immunological rejection of the graft mediated by recipient T cells, natural killer cells, and/or antibodies. Other causes are infection, recurrent disease, or an insufficient number of stem cells in the donated graft. Graft failure occurs in approximately 5% of allogeneic transplants. [6]

The rate of failure can vary by graft source, and is increased in HLA-mismatched grafts, unrelated-donor grafts, T cell-depleted grafts, and umbilical cord blood grafts. Patients allo-sensitized through prior blood transfusions or pregnancy, and those receiving reduced-intensity conditioning are also at a higher risk of experiencing graft failure.

If graft failure occurs, treatment is a second HCT, using cells from the same donor or from a different donor. Patients experiencing graft failure after a cord blood transplant cannot get backup cells from the same cord blood unit. However, it may be possible to use a different cord blood unit or a backup adult donor instead.

Early Infections

All transplant recipients are susceptible to infections and require careful monitoring, which allows for timely administration of antibacterial, antiviral, and/or antifungal agents. [7]

Average times of full immune recovery are:

Common infections in early and later post-transplant time periods are shown below.

> 0-3 Months:

> 3 Months:

Organ Injury/Toxicity

Organ injury and toxicity following transplant can include hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome, renal failure, pulmonary toxicity, thrombotic microangiopathy (TMA), and cardiovascular complications.

In the early post-transplant neutropenic period, there is an increased risk of various bacterial, fungal, and viral infections of the lung, and pneumonia develops in 40% to 60% of transplant recipients. [8] The pneumonias that can occur include herpes simplex pneumonitis, cytomegalovirus pneumonitis, and Pneumocystis carinii pneumonia.

Bronchiolitis obliterans syndrome and bronchiolitis obliterans organizing pneumonia can appear later (post day 100) in the transplant recovery period. Bronchiolitis obliterans is closely associated with chronic GVHD and may result from alloimmunologic injury to host bronchiolar epithelial cells. [8,9]

Chronic kidney disease (CKD) is associated with the use of TBI in the transplant conditioning regimen, although many cases are idiopathic. TBI-associated CKD has a typical latency of 3-6 months from irradiation to injury. CKD after transplantation may not be recognized early due to competing clinical priorities such as the treatment of GVHD, and monitoring for infections and disease recurrence. [10]

Sinusoidal obstructive syndrome (SOS) also known as veno-occlusive disease (VOD) of the liver (SOS/VOD) is the result of damage to the hepatic sinusoids, resulting in biliary obstruction. Risk factors include the use of busulfan, TBI, infection, acute GVHD, and pre-existing liver dysfunction due to iron overload or hepatitis. [11]

Transplant-associated TMA is a rare complication after allogeneic transplantation, and can occur after autologous transplantation. Risk factors for TMA include pre-transplant conditioning with busulfan, fludarabine, platinum-based chemotherapy, and total body irradiation (TBI). TMA is also associated with the use of the calcineurin inhibitors, tacrolimus and cyclosporine. Transplant-associated TMA syndromes present as hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). [12]

Cardiovascular complications may manifest as subclinical abnormalities or present as overt congestive heart failure or angina. The cardiac complications include any cardiac dysfunction due to cardiomyopathy, valvular anomaly, or conduction anomaly. [13]

Read the rest here:
Early complications of hematopoietic cell transplant

At National Stem Cell Centers, our affiliate physicians focus on leading edge, regenerative medicine. Instead of synthetic compounds, prescription medications, or surgical procedures, we activate your own natural cellular resources to promote healing.

Our goal is to allow patients access to this potentially revolutionary form of treatment to harness your bodys natural healing cascade mechanism for the repair of damaged tissues.

Adult mesenchymal stem cells are a form of undifferentiated cells. These kinds of stem cells are found in great abundance within fatty tissue. Lying dormant (non-replicating), these remarkably intelligent cells can be activated to become other kinds of cells specific to tendons, muscle, blood vessels, nerves and bone.

This means that stem cell therapies can be the key to reducing pain, chronic inflammation, and the mitigation of many degenerative disease states.

At National Stem Cell Centers, our affiliated physicians utilize only adult stem cells harvested from your own fat tissue, without any form of artificial cellular manipulation. This means that our treatments are both effective and efficacious.

Stem cell therapies may be helpful in addressing conditions and injuries such as pain, erectile dysfunction, hair loss, chronic inflammation, autoimmune disorders, orthopedic diseases, urological disorders, nerve conditions, heart and lung diseases, and more.

Call our New York office at(646) 448-0427(New York) or(516) 403-1457(Long Island) today to find out if you are a good candidate for stem cell therapy, and to schedule your complimentary consultation. National Stem Cell Centers also has locations in Southampton NY, New Jersey, Dallas and Houston in Texas, and Atlanta GA.

Link:
National Stem Cell Centers | Stem Cell Therapy in New York ...

Overview

The type and severity of the side effects from high-dose chemotherapy and allogeneic stem cell transplant are influenced by the degree of HLA matching between donor and recipient; the condition and age of the patient; the specific high-dose chemotherapy treatment regimen; and the degree of suppression of the immune system. The safety of allogeneic transplant has improved a great deal because of advancements in supportive care to manage the many potential side effects. While high doses of chemotherapy and radiation therapy can potentially affect any of the bodys normal cells or organs, the more common side effects are well described and include the following:

Bone Marrow Suppression

High-dose chemotherapy directly destroys the bone marrows ability to produce white blood cells, red blood cells and platelets. Patients experience side effects from low numbers of white blood cells (neutropenia), red blood cells (anemia) and platelets (thrombocytopenia). Patients usually need blood and platelet transfusions to treat anemia and thrombocytopenia until the new graft beings producing blood cells. The duration of bone marrow suppression can be shortened by infusing an optimal number of stem cells and growth factors that hasten the recovery of blood cell production.

Infections

During the 2-3 weeks it takes the new bone marrow to grow and produce white blood cells, patients are susceptible to infection and require the administration of antibiotics to prevent bacterial and fungal infections. Bacterial infections are the most common during this initial period of neutropenia. Stem cells collected from peripheral blood tend to engraft faster than bone marrow and may reduce the risk of infection by shortening the period of neutropenia. The growth factor Neupogen also increases the rate of white blood cell recovery and has been approved by the Food and Drug Administration for use during allogeneic stem cell transplant.

The immune system takes even longer to recover than white blood cell production, with a resultant susceptibility to some bacterial, fungal and viral infections for weeks to months. Patients are often required to take antibiotics to prevent infections from occurring for weeks to months after initial recovery from allogeneic stem cell transplant. Prophylactic antibiotic administration can prevent Pneumocystis carinii pneumonia and some bacterial and fungal infections. Prophylactic antibiotics can also decrease the incidence of herpes zoster infection, which commonly occurs after high-dose chemotherapy and allogeneic stem cell transplant.

Mucositis

Mucositis is an inflammation of the lining of the mouth or gastrointestinal (GI) tract. This condition is also commonly referred to as mouth sores. Mucositis is one of the most common side effects of the intensive therapy that precedes stem cell transplantation. The majority of patients treated with a stem cell transplant will develop mucositis. In fact, patients undergoing stem cell transplantation have complained that mucositis is the single most debilitating side effect from treatment.[1]

Chemotherapy and radiation therapy are effective at killing rapidly dividing cells, a hallmark characteristic of some cancers. Unfortunately, many normal cells in the body are also rapidly dividing and can sustain damage from chemotherapy as well. The entire GI tract, including the mouth and the throat, is made up of cells that divide rapidly. For this reason, the GI tract is particularly susceptible to damage by chemotherapy and radiation treatment, which results in mucositis.

Until recently, the only approaches to managing oral mucositis included good oral care; mouthwashes; cryotherapy (sucking on ice chips) to minimize the damage from chemotherapy drugs; Salagen, a drug that stimulates salivary flow; and other investigational treatments.

A promising new approach to the prevention and treatment of mouth sores is the use of growth factors. Growth factors are natural substances produced by the body to stimulate cell growth. The body produces many different types of growth factors. Kepivance (palifermin)is a type of growth factor that is made through laboratory processes to mimic the natural compound made in the body. Kepivance has properties that stimulate the cells that line the mouth and GI tract (called epithelial cells) to grow and develop, which may help to reduce mucositis.

Kepivance is the first FDA-approved drug for the prevention and treatment of oral mucositis. In clinical trials, Kepivance has demonstrated the ability to protect the epithelial cells from the damaging effects of radiation, and chemotherapy in patients undergoing autologous stem cell transplants[2],[3],[4],[5] and is being further evaluated to determine whether it may benefit patients undergoing allogeneic stem cell transplantation.

Veno-Occlusive Disease of the Liver (VOD)

High-dose chemotherapy can result in damage to the liver, which can be serious and even fatal. This complication is increased in patients who have had a lot of previous chemotherapy and/or radiation therapy, a history of liver damage or hepatitis. Veno-occlusive disease of the liver typically occurs in the first 2 weeks after high-dose chemotherapy treatment. Patients typically experience symptoms of abdominal fullness or swelling, liver tenderness and weight gain from fluid retention. Development of strategies to prevent or treat veno-occlusive disease is an active area of clinical investigation.

Interstitial Pneumonia Syndrome (IPS)

High-dose chemotherapy can cause damage directly to the cells of the lungs. This may be more frequent in patients treated with certain types of chemotherapy and/or radiation therapy given prior to the transplant. This complication of transplant may occur anytime from a few days after high-dose chemotherapy to several months after treatment. This often occurs after a patient has returned home from a transplant center and is being seen by a local oncologist.

Patients typically experience a dry non-productive cough or shortness of breath. Both patients and their doctors often misinterpret these early symptoms. Patients experiencing shortness of breath or a new cough after allogeneic transplant should bring this to the immediate attention of their doctor since this can be a serious and even fatal complication.

Graft-versus-Host Disease (GVHD)

Graft-versus-host disease is a common complication of allogeneic stem cell transplant. Lymphocytes contained in donated marrow or blood stem cells cause a reaction called graft-versus-host disease. In this reaction, lymphocytes from the donor attack cells in the body of the recipient especially in the skin, gastrointestinal tract and liver. The common symptoms of acute graft-versus-host disease are skin rashes, jaundice, liver disease and diarrhea. Graft-versus-host disease also increases a patients susceptibility to infection. Graft-versus-host disease can develop within days or as long as 3 years after transplantation. Generally, graft-versus-host disease that develops within 3 months following transplantation is called acute graft-versus-host disease, whereas graft-versus-host disease that develops later is called chronic graft-versus-host disease.

Removal of T-lymphocytes from the stem cell collection and immunosuppressive drugs such as methotrexate, cyclosporine, prednisone and other new agents administered after bone marrow or blood stem cell infusion are used to prevent or ameliorate graft-versus-host disease. Graft-versus-host disease can also have an anti-cancer effect because donor lymphocytes can kill cancer cells as well as normal cells. When donor lymphocytes kill cancer cells, doctors refer to this as agraft-versus-cancer effect. There are ongoing studies attempting to control this graft-versus-cancer reaction for therapeutic purposes.

Graft Failure

Graft failure occurs when bone marrow function does not return. The graft may fail to grow or be rejected in the patient resulting in bone marrow failure with the absence of red blood cell, white blood cell and platelet production. This results in infection, anemia and bleeding. Insufficient immune system suppression is the main cause of graft rejection. Graft failure may also occur in patients with extensive marrow fibrosis before transplantation, a viral illness or from the use of some drugs (such as methotrexate). In leukemia patients, graft failure often is associated with a recurrence of cancer; the leukemic cells may inhibit the growth of the transplanted cells. In some cases, the reasons for graft failure are not known.

Long-Term Side Effects of Allogeneic Stem Cell Transplant

There are several long-term or late side effects that result from the chemotherapy and radiation therapy used with allogeneic stem cell transplant. The frequency and severity of these problems depends on the radiation or chemotherapy that was used to treat the patient. It is important to have the doctors providing your care explain the specific long-term side effects that can occur for the actual treatment they propose. Some examples of complications you should be aware of include the following:

Cataracts:Cataracts occur in the overwhelming majority of patients who receive total body irradiation in their treatment regimen. In patients who receive chemotherapy without total body irradiation, cataracts are much less frequent. The onset of cataracts typically begins 18-24 months following treatment. Patients who have received large doses of steroids will have an increased frequency and earlier onset of cataracts. Patients are advised to have slit lamp eye evaluations annually and early correction with artificial lenses.

Infertility:The overwhelming majority of women who receive total body irradiation will be sterile. However, some prepubertal and adolescent females do recover ovulation and menstruation. In patients who receive chemotherapy only preparative regimens, the incidence of sterility is more variable and more age related, i.e., the older the woman is at the time of treatment the more likely chemotherapy will produce anovulation. These are important considerations because of the need for hormone replacement. All females should have frequent gynecologic follow-up.

The overwhelming majority of men who receive total body irradiation will become sterile. Sterility is much more variable after chemotherapy only regimens. Men should have sperm counts done to determine whether or not sperm are present and should be examined over time, as recovery can occur.

New cancers:Treatment with chemotherapy and radiation therapy is known to increase the risk of developing a new cancer. These are called secondary cancers and may occur as a late complication of high-dose chemotherapy. Patients treated with high-dose chemotherapy and allogeneic stem cell transplantation appear to have an increased risk of developing a secondary cancer. In a report evaluating almost 20,000 patients treated with allogeneic stem cell transplantation, 80 patients developed a new cancer. This represents an approximate 2.5% greater risk compared to normal individuals

The longer patients survived after high-dose chemotherapy and allogeneic stem cell transplantation, the greater the risk of developing a secondary cancer. Patients treated with total body irradiation appear to be more likely to develop new cancer than those treated with lower radiation doses or high-dose chemotherapy. High-dose chemotherapy and allogeneic stem cell transplant is increasingly used to treat certain cancers because it improves cure rates. Patients should be aware of the risk of secondary cancer following high-dose chemotherapy treatment and discuss the benefits and risks of high-dose chemotherapy with their primary cancer physician.

References

1. Bellm LA, Epstein JB, Rose-Ped A, et al. Patient Reports of Complications of Bone Marrow Transplantation. Support Care Cancer. 2000;8:33-39.

2. Spielberger R, Emmanouilides C, Stiff P. Use of recombinant human keratinocyte growth factor (rHuKGF) can reduce severe oral mucositis in patients (pts) with hematologic malignancies undergoing autologous peripheral blood progenitor cell transplantation (auto-PBPCT) after radiation-based conditioning results of a phase 3 trial. Proceedings of the 39th meeting of the American Society of Oncology 2003;22: Abstract #3642.

3. Emmanouilides C, Spielberger R, Stiff P, Rong A, et al. Palifermin Treatment of Mucositis in Transplant Patients Reduces Health Resource Use: Phase 3 Results. Proc Am Soc Hem. Blood. 2003;102(11):251a, Abstract #883.

4. Syrjala KL, Hays RD, Kallich JD, Farivar SS, et al. Impact of Oral Mucositis and Its Sequelae on Quality of Life. Proc Am Soc Hem. Blood. 2003;102(11):751a, Abstract #2771.

5. Stiff P, Bensinger W, Emmanouilides C, Gentil T, et al. Treatment of Mucositis with Palifermin Improves Patient Function and Results in a Clinically Meaningful Reduction in Mouth and Throat Soreness (MTS): Phase 3 Results. Proc Am Soc Hem. Blood 2003;102(11):194a, Abstract #676.

Continued here:
Complications or Side Effects of Allogeneic Stem Cell ...

Overview of PBSCT

Peripheral blood stem cell transplants, or PBSCT's, are procedures that restore stem cells that have been destroyed by high doses of chemotherapy. Stem cells are cells that give rise to the blood cells -- red blood cells that carry oxygen, white blood cells that help the body to fight infections, and platelets that help make the blood clot.

It used to be that stem cell transplants came from donated bone marrow.

Though most of the stem cells are present in bone marrow, some are out circulating -- in the peripheral blood stream. These can be collected and then transfused in patients to restore their stem cell reserve. Most stem cell transplants (but not all for a number of reasons) are now PBSCT's. Prior to donating stem cells, donors are given a medication which increases the number of stem cells in the blood. Peripheral blood stem cells work very well when compared with bone marrow transplants, and in fact, in some cases may result in platelets and a type of white blood cells known as neutrophils "taking" even better, when the donor is not related to the recipient.

In order to really understand how stem cell transplants work, it can help to talk a little more about what stem cells really are. As noted above, stem cells -- also known as hematopoietic stem cells - give rise to all the different types of blood cells in the body.

By transplanting stem cells which can subsequently differentiate and evolve into the different types of blood cells - a process called hematopoiesis - a transplant can replace a deficiency in all of the type of blood cells.

In contrast, medical treatments to replace all of these cells are intensive and carry many complications.

For example, you can give platelet transfusions, red blood cell transfusions, and give medications to stimulate both the formation of red blood cells and white blood cells, but this is very intensive, difficult, and has many side effects and complications.

Chemotherapy delivered in high doses destroys cancers better, but also destroys stem cells present in the bone marrow. Stem cell transplants help restore the bone marrow so that the patient can tolerate the high doses of chemotherapy.

There are three types of stem cell transplant:

PBSC donation involves taking circulating blood stem cells, rather than cells from the bone marrow, so theres no pain from accessing the bone marrow. But in PBSC, the medication given to boost the number of stem cells in the donors circulation can be associated with body aches, muscle aches, headaches, and flu-like symptoms.

These side effects generally stop a few days after the last dose of the stem-cell-boosting medication.

There are many possible complications of PBSCT's. The high dose chemotherapy prior to the transplant poses a serious risk of infection due to a lack of white blood cells (immunosuppression) as well as problems related to a lack of red blood cells (anemia) and low platelets (thrombocytopenia.)

A common risk after transplant is that of graft versus host disease (GvH), which happens to some degree in almost all stem cell transplants. In GvH disease the transplanted cells (from the donor) recognize the host (the recipient of the transplant) as foreign, and attack.

For this reason people are given immunosuppresive drugs following a stem cell transplant.

Yet the immunosuppressive drugs also pose risks. The decrease in immune response due to these drugs increases the risk of serious infections, and also increases the risk of developing other cancers.

Undergoing a PBSCT is a major procedure. Not only is it preceded by very aggressive chemotherapy, but the symptoms of graft versus host disease, and complications of immunosuppressive drugs make it a procedure that is usually reserved for younger, and in general very healthy, people.

One option that may be considered for patients who are older or in compromised health is a non-myeloablative stem cell transplant. In this procedure, instead of ablating (essentially destroying) the bone marrow with very high dose chemotherapy, a lower dose of chemotherapy is used. The secret behind these forms of transplants actually lies in a type of graft versus host disease. Yet, instead of the graft - the transplanted stem cells - attacking "good" cells in the recipients body, the transplanted stem cells attack the cancerous cells in the recipients body. This behavior is termed "graft versus tumor."

Also Known As:

PBSCT, Peripheral Blood Stem Cell Transplantation

Related Terms:

HSCT = hematopoietic stem cell transplantation

HCT = hematopoietic cell transplantation

SCT = stem cell transplant

G-CSF = Granulocyte-colony stimulating factor -- a growth factor, a stem cell boosting medication, sometimes given to donors to mobilize hematopoietic stem cells from the bone marrow into the peripheral blood.

Sources:

National Cancer Institute. Stem Cell Transplant. Updated 04/19/15. http://www.cancer.gov/about-cancer/treatment/types/stem-cell-transplant

Singh, V., Kumar, N., Kalsan, M., Saini, A., and R. Chandra. Mechanism of Induction: Induced Pluripotent Stem Cells (iPSCs). Journal of Stem Cells. 2015. 10(1):43-62.

Wu, S., Zhang, C., Zhang, X., Xu, Y., and T. Deng. Is peripheral blood or bone marrow a better source of stem cells for transplantation in cases of HLA-matched unrelated donors? A meta-analysis. Critical Reviews in Oncology and Hematology. 2015. 96(1):20-33.

See the article here:
Peripheral Blood Stem Cell Transplant (PBSCT) - Verywell

Article

First Online: 24 June 2008

Transplantation of bone marrow or peripheral blood stem cells is increasingly being used to treat a variety of oncologic disorders. These procedures are associated with a large spectrum of neurologic complications that significantly contribute to patient morbidity and mortality. These complications may arise at any time during and after the transplantation process and are particularly common in patients requiring chronic immunosuppression. The most frequent complications are infections and cerebrovascular or metabolic events, and toxicity from radiation or chemotherapy. Because of the unique circumstances and treatments involved in each step of the transplantation process, there is a higher incidence of some neurologic complications during discrete time periods, and an awareness of the temporal relationship of the neurologic disorder to the transplantation process facilitates diagnosis. With the exception of post-transplant lymphoproliferative disorder, in which reduced immunosuppression may be an effective therapeutic strategy, therapies are often the same as in the nontransplant patient. Complications of therapy can arise because of the presence of multiple comorbidities and medication interactions. Anticipation of common opportunistic infections and appropriate use of prophylactic medications can significantly reduce the incidence of infectious complications.

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See more here:
Neurologic complications of bone marrow and stem-cell ...

Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy forthe Crohn's disease complications.

Belgium-based TiGenix announced it received the Spanish Medicines Agency (AEMPS) license this week, explaining the Madrid plant will provide capacity for production of its portfolio of cell therapies including the candidate cell therapy Cx601.

Chief technical officer Wilfried Dalemans said: We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialization of Cx601 in Europe and in the further development of our pipeline.

Cx601 has been accepted for review by the European Medicines Agency (EMA) and Swissmedic, which began reviewing TiGenix dossier in June.

At the time the firm told us Takeda will take over responsibility for making the cell therapy from 2021 but did not provide additional details.

Manufacturing expansion

Cx601 is made from stem cells taken from donor adipose tissue. It is being developed for the treatment of complex perianal fistulas in patients with Crohns disease patients who do not otherwise respond to standard therapies.

The therapy is madein a 2-dimensional cell culture.

TiGenix expanded the Madrid facility with support from Japanese drug firm Takeda, which licensed rights to commercialize Cx601 outside the US.

In the US, TiGenix has hired Lonza to make Cx601.

In February, the Belgian biotech said Lonza is transferring manufacturing technologies to its facilities in the US, adding that the Swiss contractor is poised to begin making the product for clinical trials.

A TiGenix spokeswoman told us "Lonza will manufacture material for the global Phase 3 trial of Cx601 in the US at Lonzas cell therapy production facility in Walkersville, Maryland (US), and the GMP facility will support the potential initial European commercial roll out of Cx601."

She added that: "The expanded facility will also provide capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis."

Read the original post:
Spain OKs TiGenix's bigger cell therapy plant as firm preps for Cx601 - BioPharma-Reporter.com

STARTING secondary school is a milestone for every child, so tomorrow is going to be super special for an inspirational Barrow girl who has battled cancer and overcome complications following a stem cell transplant.

Aimee Robinson is incredibly excited to be starting Furness Academy in the morning, to join friends and make lots of new ones.

The 11-year-old was diagnosed with Acute Myeloid Leukaemia in January 2016. Aimee spent months at The Royal Manchester Children's Hospital having intensive chemotherapy to fight the cancer.

After a relapse in October last year, she went on to have a stem cell transplant using umbilical cord blood in January. Initially she responded well after spending time in isolation, but she developed graft versus host disease and had to have treatment to overcome that.

"I'd like to be a nurse or a doctor. Because I've been in hospital so much I want to help other people because the nurses and doctors helped me" - inspirational Barrow girl Aimee Robinson, 11.

In June she was well enough to return to St James's CE Junior School to complete primary school with her friends, after last being there for three weeks in September 2016.

Now after a summer of play, a bit of bike riding and family breaks, Aimee is all set to go to secondary school looking smart in her new uniform.

"I'm looking forward to starting secondary school loads, I really love school," she said.

She will be joined by her friends, including Abbie Gelling, Kian Woodburn and Sophie Miles, and said: "I want to make lots of new friends too, I've already met new people through the transition days. I'm so excited, it's a nice school."

Throughout her treatment Aimee kept up with her education through her primary school liaising with hospital tutors.

Aimee, who is a big sister to five-year-old Tilly, said: "I've always loved school, my teachers have been really nice and I just love learning.

"I really love art, music and drama, I love acting."

Asked about her ambitions, Aimee said: "I'd like to be a nurse or a doctor. Because I've been in hospital so much I want to help other people because the nurses and doctors helped me. I'm also interested in drama, because I love acting and I've been in school plays, and I like art because people say I'm good at drawing."

Happy Aimee remained upbeat in hospital, she said: "I just thought there could be people much worse than me and there is no point in moaning about it, I can still do stuff. The play leaders helped by giving me loads to do, I pretty much did all the stuff that was in the cupboard. I liked helping other young people."

Her treatment has now stopped, but she has clinic appointments at hospital to take blood counts.

Aimee family are incredibly proud of her, mum Joanne Robinson, 39, said: "I'm extremely proud of Aimee, she is a super star.

"I'm happy, we are home now and Aimee can get back into normal things.

"Furness Academy is a lovely school and I think Aimee will thrive there."

Aimee also has some charity challenges in her sights, she said: "When I get stronger I really want to do the Coniston to Barrow with Aimee's Army and raise money for The Royal Manchester Children's Hospital and The Children's Cancer and Leukaemia Group."

Here is the original post:
Barrow's inspirational Aimee can't wait to start secondary school - NW Evening Mail

The Potential Dangers of Treating Chronic Lyme Disease

Chronic Lyme disease is sometimes a catchall diagnosis for patients with a wide spectrum of musculoskeletal and neuropsychiatric symptoms, fatigue, and generalized pain. And that, in turn, has led to a variety of treatments: courses of antibiotics lasting for months to years, intravenous (IV) infusions of hydrogen peroxide, immunoglobulin therapy, and even stem cell transplants. Those treatments, though, may not lead to substantial long-term improvementin fact, they can be downright harmful.

Clinicians, health departments, and patients have all contacted the Centers for Disease Control and Prevention with reports of life-threatening complications resulting from treatment for chronic Lyme disease, including metastatic bacterial infections, septic shock, Clostridium difficile colitis, and abscesses. Morbidity and Mortality Weekly Report (MMWR) describes five cases that highlight the severity and scope of adverse effects caused by the use of unproven treatments for chronic Lyme disease.

One patient with fatigue and joint pain, for instance, was diagnosed with chronic Lyme disease, babesiosis, and Bartonella infection. When her symptoms worsened despite multiple courses of oral antibiotics, she was switched to IV ceftriaxone and cefotaxime. However, the pain did not lessen; she became hypotensive and tachycardic, and was placed in intensive care. Her condition continued to worsen, and she died. Her death was attributed to septic shock related to central venous catheter-associated bacteremia.

In another case, a woman was first diagnosed with amyotrophic lateral sclerosis (ALS), then, as a second opinion, with chronic Lyme disease. After seven months of intensive antimicrobial treatment, the pain improved, but she got weaker. She also developed intractable C. difficile infection that required prolonged treatment. However, she died of complications of ALSan example, the researchers say, of a missed opportunity for appropriate treatment due to misdiagnosis.

Antibiotics and immunoglobulin therapies are effective and necessary treatments for many conditions, MMWR emphasizeshowever, unnecessary antibiotic and immunoglobulin use provides no benefit to patients while putting them at risk for adverse events.

Source: MMWR, June 2017

Current treatments for Parkinsons disease are only effective in improving motor deficits, but the loss of cognitive abilities is just as devastating. Approximately 25% of patients also experience cognitive deficits that impair function. One problem in developing treatments, however, is that patients with cognitive effects vary widely. Being able to predict the chance that someone with Parkinsons will develop cognitive deficits could be a useful tool, researchers from Brigham and Womens Hospital say. And they think they might have created just the thing: a computer-based risk calculator.

The researchers combined data from 3,200 patients with Parkinsons disease, representing more than 25,000 individual clinical assessments. They evaluated seven known clinical and genetic risk factors associated with developing dementia, and then used the information to build the risk calculator.

By allowing clinical researchers to identify and select only patients at high risk for developing dementia, this tool could help in the design of smarter trials that require a manageable number of participating patients, says Clemens Scherzer, MD, the lead investigator.

By improving clinical trial design, the risk calculator could help in the discovery of new treatments, the researchers say, and then help determine which patients would most benefit from those treatments.

Source: National Institutes of Health, June 2017

Some patients with acute myeloid leukemia (AML) may have trouble with immunotherapy after chemotherapy, researchers say, and they think theyve found one reason why.

The team wanted to perform a deep assessment of the state of the adaptive immune system in AML patients in remission after chemotherapy. They used the response to seasonal influenza vaccination as a surrogate for the robustness of the immune system. They say their approach was unique in that they established a comprehensive picture of the adaptive immunome by simultaneously examining the genetic, phenotypic, and functional consequences of chemotherapy.

Their assessment revealed a dramatic impact in the B-cell compartment, which appeared slower to recover than the T-cell compartment. Of 10 patients in the study, only two generated protective titers in response to vaccination. Most had abnormal frequencies of transitional and memory B cells. The researchers say the inability of AML patients to produce protective antibody titers in response to influenza vaccination is likely due to multiple B-cell abnormalities. They found similar patterns across all of the patients. When they ranked patients based on time elapsed since chemotherapy, the degree of dysfunction was lesser in patients who were farther away from chemotherapy.

The consistent finding of a reduction of memory B cells in all the AML patients suggests that humoral immunity reconstitution is a very long process. The researchers say that a better understanding of the changes in adaptive immune cell subsets after chemotherapy will be useful in designing immunotherapies that can work with existing immune capacity.

Source: Journal of Translational Medicine, July 2017

Investigation by the Centers for Disease Control and Prevention (CDC) of 27 outbreaks of Legionnaires disease between 2000 and 2014 found health-careassociated Legionnaires disease accounted for 33% of the outbreaks, 57% of outbreak-associated cases, and 85% of outbreakassociated deaths. Nearly all were attributed to water system exposures that could have been prevented by effective water management programs.

CDC researchers analyzed 2015 surveillance data from 20 states and the New York City metropolitan area that reported more than 90% of confirmed legionellosis cases to the Supplemental Legionnaires Disease Surveillance System. Of 2,809 cases, 553 were health-careassociated. Definite cases accounted for 3%, and possible cases accounted for 17% of all of the cases reported. Although only a small percentage was definitely related to health care settings, the fatality rate was high at 12%.

Of the 85 definite health-careassociated Legionnaires disease cases, 80% were associated with long-term-care facilities. Of the 468 possible cases, 13% were possibly associated with long-term-care facilities, 49% with hospitals, and 26% with clinics.

The CDC says the number of definite cases and facilities reported is likely an underestimate, in part because of a lack of Legionella-specific testing. Another explanation is that hospital stays are typically shorter than the 10-day period used in the analysis.

One-fourth of patients with definite health-careassociated Legionnaires disease die. Health care providers play a critical role in prevention and response, the CDC says, by rapidly identifying and reporting cases. Legionnaires disease is clinically indistinguishable from other causes of pneumonia, the researchers note. The preferred diagnostic method is to concurrently obtain a lower respiratory sputum sample for culture on selective media and a Legionella urinary antigen test.

In health care facilities, the researchers say, prevention of the first case of Legionnaires disease is the ultimate goal. The best way to do that, they advise, is to have an effective water management program.

Source: Morbidity and Mortality Weekly Report, June 2017

Metabolic syndrome (MetS) is common among patients with coronary artery disease (CAD) and highly prevalent in those with acute ST-elevation myocardial infarction (STEMI). But are all elements of MetS equally good predictors of clinical severity and prognosis?

To find out, researchers from Sestre Milosrdnice University Hospital Center in Zagreb, Croatia, prospectively analyzed data from 250 patients with acute STEMI treated with primary percutaneous coronary intervention. MetS was defined according to the revised National Cholesterol Education ProgramAdult Treatment Panel III (NCEPATP III) and International Diabetes Federation (IDF) criteria. Of the 250 patients, 231 survived for inclusion in the 12-month follow-up.

Patients with and without MetS were analyzed according to obesity indices: body mass index (BMI), central-body adiposity index (BAI), conicity index (Cindex), visceral adiposity index (VAI), waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR).

Patients with acute STEMI had high rates of central obesity, increased VAI, WHtR, and very high BAI, dyslipidemia, and hypertension. However, they had lower rates of overall obesity and hyperglycemia.

The NCEPATP III and several other obesity indices were superior to overall obesity (BMI) in predicting acute STEMI severityclinical presentation, in-hospital complications, and severity of CAD. WC and MetS as defined by IDF criteria had no influence on it. Moreover, MetS as defined by NCEP-ATP III or IDF and obesity indices had no influence on prognosis of major adverse cardiovascular events (MACE).

Cindex greater than 1.25/1.18, very high BAI, and WHtR of 63/58 or greater increased the risk of total in-hospital complications, dyspnea, and heart failure, respectively. The number of significantly stenosed coronary arteries increased the risk of total MACE. WHR independently increased the risk of significant stenosis of coronary segment 1 and proximal/middle coronary artery segments.

Source: Archives of Medical Science, June 2017

A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to a recent study.

Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. However, multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophoresthe part of the molecule responsible for its colorand exogenous contrast agents based on their spectral signatures.

The researchers performed MSOT imaging with handheld scanners on 21 patients with nonmelanoma skin cancers. All of the lesions had recognizable images on the MSOT devices, visualizing the shape and thickness of the lesions and providing images with well-resolved tissue chromophores.

Aggressive types of skin cancers can involve deeper structures, the researchers noteanother reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.

Source: Photoacoustics, June 2017

Originally posted here:
Research Briefs September 2017 - P&T Community

The US Food and Drug Administration (FDA) intendsto investigate the use of unproven stem cell therapies being offered in the country'sclinics.

Tighter enforcement from the FDA comes as an inspection at StemImmune Inc based in San Diego, California, revealed the use of potentially dangerous treatments administered to vulnerable cancer patients.

Only a small number of stem cell treatments are currentlyFDA approved, including use of bone marrow transplants in cancer patients and cord blood for specific blood-related disorders.However stem cell treatments using only the patient's own cells are not subject to the same level of regulation as drugs if the cells are only 'minimally manipulated'.

FDA commissioner Dr Scott Gottlieb said in a statement:'The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'

Five vials,each containing 100 doses of the live Vaccinia Virus Vaccine, were seized from StemImmune Incby US marshals on25August 2017.

The vaccine, which is usedagainst smallpox, and is not commercially available was combined with stem cells derived from body fat to create an unapprovedtherapy. The concoction was injected directly into tumours of cancer patients at California Stem Cell Treatment Centres in Rancho Mirage and Beverly Hills.

The effects of the vaccine in immunocompromised cancer patients have the possibility to cause severe complications such as inflammation and swelling of the heart and surrounding tissues.

In a separate case, awarning letter was also sent to chief scientific officerKristin Comellaat US Stem Cell Clinic in Sunrise, Florida, after three patients with macular degeneration were blinded following the use of unapproved stem cell injections into their eyes, in a sponsored study (see BioNews 893). The letter lists a number of non-compliance to procedures and 'significant deviations' to current good manufacturing practice and good tissue practice.

'Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,' Dr Gottlieb commented. 'I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch a safety reporting programme.'

Professionals in the field blame the past lack of FDA attention for the widespread problem and are calling for stringent regulation. ProfessorLeigh Turner, fromthe Centre for Bioethics at the University of Minnesota, told CNN: 'This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority.'

Read more from the original source:
FDA crackdown on unproven stem cell therapies - BioNews

RACHEL THOMAS

Last updated19:30, August 30 2017

SUPPLIED

Tiny rat hearts growing in dishes in a move that Australian plastic surgeon Wayne Morrison hopes will one day be able to help humans.

"We're growing little beating hearts in dishes," Professor Wayne Morrison says, deadpan.

The man behind Australia's first hand transplanthas spent his life reattaching and transplanting body parts. Now he's working to see if we can regrow them ourselves.

As part of his work as director of Melbourne's BernardO'Brien Instituteof Microbiology, Morrison hasgrown hearts to maturity on the legs of rats and retransplanted them inside their bodies.

RACHEL THOMAS/STUFF

Morrison with leading Kiwi plastic surgeon Swee Tan at the Gillies McIndoe Research Institute in Wellington.

The next step is humans:"Our core interestis in trying to grow fat tissue and skin to repair people."

READ MORE:*Christchurch research key to printing human body parts*Scientists convert spinach leaves into human hearttissue that beats*Grant for NZ scientist seeking ways to use fish eyes to repair human corneas

With this in mind, he has been in Wellington to talk tissue engineering with leading plastic surgeon SweeTan, founder of the Gillies McIndoe Research Institute (GMRI) in Newtown, as well as to give a public lecture on his work.

RACHEL THOMAS/STUFF

The cell and tissue culture lab at the Gillies McIndoe Research institute, where Tan is engineering tissue.

We're "miles away" from growing a fully functional heart for humans, Morrison said, but the work could have a massive impactfor burns victims, mastectomy patients, and those waiting for vital organs such as lungs and hearts in the future.

"First, you want to be able to grow tissue that will not be rejected."

It all comes down tofiguring out how the building blocks of the body stem cells lead to growth of new tissue.

REUTERS

A rat with a human ear growing on its back, reportedly pictured by a Shanghai university in the 1990s. Morrison hopes a similar process can be used to grow vital organs for human transplants in the future.

New developments mean expertscan take a piece of skin and recreate the embryo which means it can be manipulated and growninto any type of tissue, he said.

Tanhas pioneered research at GMRIon targeting specific cancer stem cellswhich if manipulated properly would mean doctors could nip certain types of cancer in the bud.

InMelbourne, Morrison recentlytrialleda way ofregrowingbreastsin four mastectomy patients.

About 30mlof fatty tissue was inserted under the skin in a 200ml special chamber,and in one patient, that chamber filled completely with new tissue.

The key is to understand how that happened, and why it didn't work in the three other patients. "It is a principle, that you can grow or expand tissue."

A long-time plastic surgeon, Morrison has always been in the business of putting people back together.

He cited a "face amputation" about 20 years ago as the most complex and rewardingprocedures he's ever done.

An Australian womangot her ponytail caught in a milking machine near Melbourne. She was scalped from the back of her head down to her jawline.

"This one, extraordinarily, took the whole face off. I think there's only one other ever been reported in the world.

"Reattachingthat took 24 hours or so, and we didn't know if it would surviveor not. Fortunately the face did;a lot of the scalp tissue did not."

It's those horrifying cases thatled to both him and Tan seekingmore solutions for victims of cancer or freak accidents.

"Thecomplications of the drugs you have to take are morbid, and they will eventually kill you."

Frenchwoman IsabelleDinoirewas theworld's first recipient of afacialtransplant in 2005, butdied last year after developing two kinds ofof cancer.

But as Morrison says: "If you see someone with facial injuries or burns, you'd need a hard heart to say, 'No, you can't have a transplant' that would be horrendous."

-Stuff

More here:
Recreating breasts and beating hearts: how tissue engineering is changing medicine - The Dominion Post

DUBLIN--(BUSINESS WIRE)--The "Global Cartilage Repair Market 2017-2021" report has been added to Research and Markets' offering.

The global cartilage repair market to grow at a CAGR of 11.59 % during the period 2017-2021.

The treatment of articular cartilage has evolved tremendously in the past decade. Reparative and restorative methods have been developed to address the significant source of morbidity in the young and active patients. Articular cartilage injury can be focal, which is localized or systemic. Procedures are being developed not only to alleviate the symptoms associated with articular cartilage defects but also to limit the progression of cartilage damages into degenerative diseases.

According to the report, one of the major drivers for this market is Rising incidence of accidental injuries. Globally, the road traffic injuries are increasing, with post complicated symptoms such as weakening of tendons, cartilage tear, and orthopedic issues.

The latest trend gaining momentum in the market is Gene therapy and stem cell therapy. Gene therapy is one of the promising fields in the cartilage repair. Many clinical studies have been performed for cartilage repair. The researchers are trying to develop gene therapy for cartilage repair and currently been investigated for clinical application.

Further, the report states that one of the major factors hindering the growth of this market is Product side effects. Surgeons use cartilage repair products such as tissue scaffold to improve the recovery. These products once grafted in the body may cause serious complications, resulting in their increased scrutiny for safety and efficacy. In many autologous chondrocyte implantation, there were common complications such as graft rejection, symptomatic hypertrophy, disturbed fusion and delamination.

Key vendors

Other prominent vendors

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/research/rjx284/global_cartilage

Originally posted here:
Global Cartilage Repair Market 2017-2021 - Gene Therapy and Stem Cell Therapy is the latest Market Trend Making ... - Business Wire (press release)

The Independent Citizens Oversight Committee of the California Institute for Regenerative Medicine (CIRM) today unanimously approved an $18.29 million grant to University of California San Diego School of Medicine researchers to fund a phase Ib/IIa clinical trial of a novel combination drug therapy for B-cell cancers.

Scanning electron micrograph of B lymphocyte. Image courtesy of National Cancer Institute.

The approach combines an experimental monoclonal antibody-based drug called cirmtuzumab with ibrutinib, a small molecule drug that inhibits a protein called Brutons tyrosine kinase. Ibrutinib, marketed as Imbruvica, is already approved to treat B cell cancers, like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Cirmtuzumab targets ROR1, a cell surface protein present on tumors but not in normal adult tissues a distinction that makes it an attractive target for anticancer therapy. Cirmtuzumab is currently in clinical trials for the treatment of CLL.

The new combined drug trial, intended to study both safety and efficacy, is headed by Thomas Kipps, MD, PhD, Distinguished Professor of Medicine and deputy director of research at UC San Diego Moores Cancer Center, in collaboration with colleagues at the UC San Diego CIRM Alpha Stem Cell Clinic the cell therapy arm of the Sanford Stem Cell Clinical Center at UC San Diego Health.

We are very excited about evaluating this combination of targeted therapies in the clinic, said Kipps. Although ibrutinib has been approved for treatment of patients with CLL or MCL, it is exceptionally rare for this drug by itself to get rid of all the leukemia cells or cause long-lasting remissions without continuous therapy.

As a result, patients are recommended to take ibrutinib indefinitely until they develop intolerance or resistance to this drug. By blocking a survival/growth-stimulating pathway that provides a lifeline to the leukemia cells of patients taking ibrutinib, cirmtuzumab can work together with ibrutinib to potentially kill all the leukemia cells, allowing patients to achieve a complete remission and stop therapy altogether.

Kipps noted, too that cirmtuzumab targets cancer stem cells, which behave somewhat like the roots of the disease, resisting many forms of treatment and allowing a malignancy to grow back after apparently successful therapy. By targeting cancer stem cells, said Kipps, cirmtuzumab may improve our capacity to achieve more complete and longer lasting remissions when used in combination with targeted drugs, such as ibrutinib, or other anti-cancer drugs for the treatment of patients with many different types of cancer.

B cell malignancies are cancers of the blood. B cells are a type of white blood cell or lymphocyte, part of the immune system. Some B cells produce antibodies to immediately help fight off infections while others, called memory B cells, remember the pathogen in case of future infections. In B cell cancers, mutated B cells dysfunction or grow in an uncontrolled manner, resulting in diseases like CLL (the most common type of leukemia) and most non-Hodgkins lymphomas.

Cirmtuzumab was developed in Kipps laboratory under the auspices of CIRMs HALT leukemia grant awarded to Dennis Carson, MD, principal investigator, and Catriona Jamieson, MD, PhD, deputy director of the Sanford Stem Cell Clinical Center and director of stem cell research at Moores Cancer Center. Kipps led one of the six projects, generating antibodies against ROR1 that, ultimately, led to the cirmtuzumab trials in patients with CLL.

Every year around 20,000 Americans are diagnosed with CLL, said Maria Millan, MD, interim president and CEO of CIRM. For those who have run out of treatment options, the only alternative is a bone marrow transplant. Since CLL afflicts individuals in their 70's who often have additional medical problems, bone marrow transplantation carries a higher risk of life-threatening complications. The combination approach of cirmtuzumab and Ibrutinib seeks to offer a less invasive and more effective alternative for these patients.

Cirmtuzumab has also shown efficacy against solid tumors. A clinical trial is planned to test it, in combination with the drug paclitaxel, for treating metastatic breast cancer. That trial is not yet recruiting participants. Cirmtuzumabs name is a nod to CIRMs long-standing support and research funding.

CIRM was created in 2004 by California voters with $3 billion in funding support to accelerate stem cell research and treatments. Since 2004, UC San Diego researchers have received at least 96 CIRM awards, totaling more than $182 million.

Continued here:
State's Stem Cell Agency Awards $18.2 Million Grant for B Cell Cancer Clinical Trial - UC San Diego Health

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From clot-busting drugs to bypass surgery, cardiologists have many options for treating the 700,000-plus Americans who suffer a heart attack each year. But treatment options remain limited for the 5.7 million or so Americans who suffer from heart failure, an often debilitating condition in which damage to the heart (often resulting from a heart attack) compromises its ability to pump blood.

Severe heart damage can pretty much incapacitate people, says Dr. Timothy Henry, director of cardiology at the Cedars-Sinai Medical Center in Los Angeles. You cant climb a flight of stairs, youre fatigued all the time, and youre at risk of sudden cardiac arrest.

Medication is available to treat heart failure, but its no panacea. And some heart failure patients undergo heart transplantation, but it remains an iffy proposition even 50 years after the first human heart was transplanted in 1967.

But soon, there may be another option.

A patch for the heart

Researchers are developing a new technology that would restore normal cardiac function by covering scarred areas with patches made of beating heart cells. The tiny patches would be grown in the lab from patients own cells and then surgically implanted.

The patches are now being tested in mice and pigs at Duke University, the University of Wisconsin and Stanford University. Researchers predict they could be tried in humans within five years with widespread clinical use possibly coming within a decade.

The hope is that patients will be again to live more or less normally again without having to undergo heart transplantation which has some serious downsides. Since donor hearts are in short supply, many patients experiencing heart failure die before one becomes available. And to prevent rejection of the new heart by the immune system, patients who do receive a new heart typically must take high doses of immunosuppressive drugs.

Heart transplants also require bypass machines which entails some risk and complications, says Dr. Timothy Kamp, co-director of the University of Wisconsins Stem Cell and Regenerative Medicine Center and one of the researchers leading the effort to create heart patches. Putting a patch on doesnt require any form of bypass, because the heart can continue to pump as it is.

To create heart patches, doctors first take blood cells and then use genetic engineering techniques to reprogram them into so-called pluripotent stem cells. These jack-of-all-trade cells, in turn, are used to create the various types of cells that make up heart muscle. These include cardiomonocytes, the cells responsible for muscle contraction; fibroblasts, the cells that give heart tissue its structure; and endothelial cells, the cells that line blood vessels.

These cells are then grown over a tiny scaffold that organizes and aligns them in a way that they become functional heart tissue. Since the patches would be made from the patients own blood cells, there would be no chance of rejection by the patients immune system.

Once the patch tissue matures, MRI scans of the scarred region of the patients heart would be used to create a digital template for the new patch, tailoring it to just the right size and shape. A 3D printer would then be used to fabricate the extracellular matrix, the pattern of proteins that surround heart muscle cells.

The fully formed patch would be stitched into place during open-heart surgery, with blood vessel grafts added to link the patch with the patients vascular system.

In some cases, a single patch would be enough. For patients with multiple areas of scarring, multiple patches could be used.

Inserting patches will be delicate business, in part because scarring can render heart walls thin and susceptible to rupture. Researchers anticipate that heart surgeons will look at each case individually and decide whether it makes more sense to cut out the scarred area and cover the defect with a patch or simply affix the patch over the scarred area and hope that, over time, the scars will go away.

Another challenge will be making sure the patches contract and relax in synchrony with the hearts onto which theyre grafted. We think this will happen because cells of the same type like to seek each other out and connect over time, Kamp says. We anticipate that if the patch couples with the native heart tissue, the electrical signals which pass through the heart muscle like a wave and tell it to contract, will drive the new patch to contract at the same rate.

How much would it cost to patch a damaged heart? Researchers put the price tag at about $100,000. Thats far less than the $500,000 or so it costs give a patient a heart transplant. And regardless of the cost, researchers are upbeat about the possibility of having a new way to treat heart failure.

Using these patches to repair the damaged muscle is likely to be very effective, says Henry. Were not quite there yet itll be a few years before you see the first clinical trials. But this technology may really provide a whole new avenue of hope for people with these conditions who badly need new treatment options.

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'Beating Heart' Patch Offers New Hope for Desperately Ill Patients - NBCNews.com

US marshals on Aug 25 confiscated five vials of vaccinia virus vaccine, reserved only for military members and other people at high risk of smallpox, from a California clinic, part of an effort to prevent a company from using potentially dangerous and unproven treatments for cancer patients.

The Food and Drug Administration (FDA) said today in a statement that the treatments belonging to StemImmune, Inc., based in San Diego, were given to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.

Authorities seized five vaccina virus vaccine vials, each of which contained 100 doses. One vial was partially used, and the other four were still intact. Because the vaccine is not commercially available, the FDA said it has serious concerns about how StemImmune obtained the product and is actively investigating the circumstances.

FDA Commissioner Scott Gottlieb, MD, said in the statement, "Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures." In the past, Gottlieb was successfully treated for Hodgkin's lymphoma, according to a May 10 report from the Los Angeles Times.

He added that the FDA won't allow companies to take advantage of vulnerable patients with no proof that the treatments work, especially when there are good medical reasons to believe that the treatments are harmful and could worsen a patient's condition.

The seizure of the vials came after FDA inspections at StemImmune and California Stem Cell Treatment Centers found that the vaccinia vaccine was used to create an unapproved stem cell product, made from excess amounts of vaccine and stem cells derived from body fat. The combination was administered to cancer patients who had potentially compromised immune systems and for whom the vaccine could have triggered serious complications, including myocarditis and pericarditis.

According to the FDA, the unproven treatment was injected intravenously and directly into patients' tumors.

Besides the threat to cancer patients, people in close contact with those who have recently received the vaccinia virus vaccinefor example, pregnant women, people with weakened immunity, and those with certain skin conditionscan experience life-threatening complications after secondary infection.

Gottlieb said he has directed the FDA to vigorously investigate unscrupulous clinics using a full range of enforcement tools. "Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk." He also urged health providers, patients, and consumers to report similar activities and adverse reactions from such treatment to the FDA.

Smallpox was eradicated in 1980, but samples are kept in labs in the United States and Russia for research purposes, and there are concerns that samples that may exist elsewhere may be used for bioterrorism.

In the wake of the terrorist attacks of 2001, the United States has built up a stockpile of three smallpox vaccines: ACAM2000, Aventis Pasteur Smallpox Vaccine, and Imvammune. They contain live vaccinia virus, a cousin of the smallpox (variola) virus. The FDA statement didn't say what formulation was seized by the US marshals.

See also:

Aug 28 FDA news release

May 10 LA Times story

Original post:
Feds seize vaccinia virus vaccine used in 'stem cell' centers - CIDRAP

HOUSTON, Aug. 17, 2017 /PRNewswire/ --ViraCyte, LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe viral infections, today announced notification of funding approval for a Product Development Research grant totaling $8.99 million by the Cancer Prevention and Research Institute of Texas (CPRIT) Oversight Committee to support the clinical development of the Company's lead product, Viralym-M a "ready to administer" multivirus-specific T cell immunotherapy.

Under the Product Development Research Program, CPRIT supports Texas-based companies and institutions by funding projects developing disruptive, commercially-oriented technologies with the overall goal of improving outcomes in patients with cancer. Pending successful negotiations and contract execution, the CPRIT award, entitled Improving Outcome of Stem Cell Transplants for Cancer Treatment Using Multi-Virus Specific T cells, will support an advanced clinical trial testing the safety and efficacy of Viralym-M in adult and pediatric cancer patients.

"ViraCyte is dedicated to improving the outcomes of stem cell transplant recipients and further developing T cell immunotherapy for viral complications for which there are no currently approved treatments available," stated Dr. Ann Leen, Chief Scientific Officer at ViraCyte. "We are extremely grateful to CPRIT and the Oversight Committee for their positive review and funding recommendation of this award."

About ViraCyte, LLC

ViraCyte's current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte's lead T cell products are in Phase 2 and Phase 1 clinical trials, with effectiveness rates of greater than 94% in patients who have failed conventional therapy. More information can be found atwww.viracyte.com

ViraCyte is a resident company at JLABS @ TMC, Houston, Texas.

View original content:http://www.prnewswire.com/news-releases/viracyte-awarded-899m-from-the-cancer-prevention-and-research-institute-of-texas-300506283.html

SOURCE ViraCyte, LLC

Excerpt from:
ViraCyte Awarded $8.99M from the Cancer Prevention and ... - Markets Insider

Its human nature to want a quick fix in resolving issues or problems. Getting maximum results with minimal effort certainly has its appeal. From Thigh Masters and Bowflexes to The Clapper and Ginsu knives, the promise for rapid results and convenience can draw consumers in like the late-night glow of the TV infomercials selling these items.

But, lets be honest, these examples may have yield their desired results, but most products end up being a total disappointment and waste of money. This is also the case with certain medical procedures or therapies claiming to fix certain ailments or chronic conditions. As a patient-consumer, its important to do your research and not let emotions or false hopes guide you into making a potentially expensive or even risky decision involving your health.

One item in general, stem cell therapy, has been getting quite a bit of attention of late. Many may ask, what are stem cells? Stem cells are cells that have the potential to develop into many different types of cells. Think of them as a blank canvas which can divide and become specialized cells within the body such as blood, liver, or muscle cells. Stem cell therapy acts by introducing these cells into some areas of the body, to which the stem cells can divide regularly to regenerate and/or repair existing tissue. Stem cell therapy has long been used by physicians to treat certain types of cancers, such as leukemia and lymphoma as well as treating some bone, skin, and corneal eye injuries. But, while stem cells continue to be studied as potential treatments for other ailments and conditions, there are very few of these treatments currently that have been proven to be effectivelet alone safe.

With catchy, even gimmicky, tag lines like make me walk again, feel young again, or no surgery, no side effects, clinics (both in the United States and outside of it) are offering stem cell therapy to treat a laundry list of conditions. The problem with it is patient testimonials and gimmicky marketing techniques can be misleading. One resource beneficial in better understanding stem cell therapies is the International Society for Stem Cell Research (ISSCR). It represents academia and industry on a broad range of issues that affect the well-being of patients and their families, and strives to educate the public and government regulators on the basic principles of stem cell science and the realistic potential for new medical treatments and cures.

According to the ISSCR, when there is no existing or effective treatment for a disease or condition it is easy to understand why you may feel there is nothing to lose from trying something new, even if it isnt proven. Unfortunately, most of the unproven stem cell treatments for sale throughout the world carry very little promise of actual benefit and very real risks.

Many stem cell therapy clinics may offer the use of a patients own cells, also known an autologous transplant. In theory, your immune system would not attack your own cells if they were used in a transplant. However, the processes by which the cells were acquired, grown and then reintroduced into the body would carry risks. Here are just a few known risks of autologous stem cell treatments:

If you have thought about or are considering stem cell therapy, first get the guidance of your primary healthcare provider. They can help guide you in obtaining the right literature and evidence in help making the right decision for the safest and most effective treatments available. Snake oil salesmen exist in every industryincluding those wearing white lab coats. Choose your care wisely.

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STONE: Certain medical practices can prey on false hopes - Odessa American