StemCell Therapy

LEXINGTON, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that it has completed enrollment of its placebo-controlled Phase 2b study of FX-322 in adults with acquired sensorineural hearing loss (SNHL). The FX-322-208 study, which enrolled 142 individuals, is designed to show improvement in a pre-specified measure of speech perception. The Company plans to release study data in the first quarter of 2023.

I am very pleased with our teams execution of this study for the first potential treatment to restore hearing for those with SNHL. The 208 study was rigorously designed to ensure the stability of an individuals hearing prior to entering the trial and to exclusively enroll those with the types hearing loss where we observed the strongest hearing improvement in prior FX-322 studies. FX-322 continues to have a favorable safety profile and we are aligned with FDA on the primary speech perception endpoint. With a successful outcome of this single-dose study, our intent is to advance the program into Phase 3 trials, said David L. Lucchino, Frequencys chief executive officer.

Mr. Lucchino continued: We are grateful to all the study volunteers, clinicians and site staff for their time and commitment to this trial. We believe the high level of interest from patients and healthcare providers in this study further demonstrates the need for a novel, disease modifying hearing loss treatment to expand the standard of care for the millions of individuals with sensorineural hearing loss.

FX-322-208 Study Design

FX-322-208 is a prospective, randomized, double-blinded, placebo-controlled, multi-center Phase 2b study designed to evaluate the efficacy of a single administration of FX-322 on speech perception in subjects aged 18-65 with hearing loss associated with either noise-induced or permanent idiopathic sudden SNHL. The study enrolled 142 participants, exceeding the original enrollment target of approximately 124, and is being conducted at 28 clinical sites across the US.

The Company previously aligned with the US Food and Drug Administration (FDA) on the use of the specific speech perception primary endpoint. With improved speech perception, individuals may hear words more clearly, a critical unmet need for individuals with hearing loss. The FX-322-208 study is powered at 80% (significance level of 0.05) to observe a statistically significant and clinically meaningful improvement in speech perception at day 90 following dosing, with study responders defined as individuals exceeding the upper 95% confidence interval in the speech perception test. The Company has not publicly disclosed the specific test used for the primary endpoint to maximize the rigor of the study and mitigate potential bias.

During the study, subjects participate in a range of audiologic exams, including pure-tone audiometry, word recognition in quiet, word recognition in noise, the Tinnitus Functional Index (TFI), as well as multiple patient-reported outcome measures including Frequencys proprietary patient reported outcome instrument (RADIAL) in acquired SNHL. All subjects are required to have a documented audiogram from at least six months prior to screening and most patients are evaluated over a 270-day period following dosing. The studys rigorous design includes a lead-in phase with multiple baseline measures. Subjects with instability of baseline tests are disqualified from participation in the study. Study audiometry testing sessions are recorded and monitored by third party audiologists to ensure consistency and identify any anomalies related to how tests were conducted.

In prior studies, the Company observed the greatest concentration of speech perception improvements in individuals with permanent sudden or noise-induced sensorineural hearing loss in the moderate to lower severe hearing loss range. These learnings informed the design and inclusion criteria for the FX-322-208 study. More than 200 individuals have been dosed with a single injection of FX-322 in prior or ongoing studies, and the drug candidate has continued to exhibit a favorable safety profile with no drug-related serious adverse events.

About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to sensory hair cells in the cochlea. These cells convert sound waves to signals sent to the brain which are interpreted as speech and sound. Sensory hair cells are lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of hearing loss impacts around 40 million individuals in the U.S. alone.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of the Phase 2b study (FX-322-208), including the timing of results and the ability of design features to reduce bias, the commencement of any future FX-322 trials, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the treatment potential of FX-322, estimates of the size of the hearing loss population, the acceptance by the FDA of particular endpoints in the Companys trials, and the potential application of the progenitor cell activation (PCA) platform to other diseases.

These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Companys ongoing and planned clinical trials, research and development and manufacturing activities, the Companys business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Companys need for additional funding to complete development and commercialization of any product candidate; the Companys dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Companys limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; ability to seek and receive Breakthrough Therapy designation for FX-322; the Companys ability to enroll and retain patients in clinical trials; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including healthcare and environmental, health, data privacy and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attracting and retaining key personnel; and the Companys ability to manage growth.

These and other important factors discussed under the caption Risk factors in the Companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.

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Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Business Wire

While sea moss has been harvested and consumed either as food or for healing for thousands of years, there is limited scientific evidence to prove many of these claims, says Carrie Lam, M.D., a physician specializing in family medicine and anti-aging and regenerative medicine at The Lam Clinic in Tustin, California. However, new research into its benefits shows promise in the ability of sea moss to treat inflammation and related disorders, she adds.

There are more studies on the benefits of seaweeds as a whole than on sea moss itself. Preliminary research on sea moss thus far is based on small studies. Large-scale clinical trials are needed to verify the findings listed below.

Your thyroid [a small gland located at the base of your neck] needs iodine to produce thyroid hormones, says Dr. Lam. These hormones, important for proper thyroid function, also play a role in metabolism, she explains. Iodine must be acquired through diet because the body cannot make it on its own.

An iodine deficiency can lead to an enlarged thyroid (or goiter), hypothyroidism and intellectual disabilities in infants and children whose mothers were iodine deficient during pregnancy, according to the American Thyroid Association.

While iodine deficiency has been virtually eliminated in the U.S. since the introduction of iodized salt, even a minor deficiency can cause adverse effects on the thyroid.

In the marine environment, seaweeds are the largest supplier of iodine. However, the iodine content varies among different species, with brown seaweed typically having a greater amount compared to green and red seaweeds. Sea moss in particular contains an average of 3.86 1.49 milligrams of iodine per kilogram dry weight.

Most adults need about 150 micrograms of iodine a day, with pregnant and lactating individuals needing slightly more at 220 micrograms and 290 micrograms, respectively, according to the National Institutes of Health.

An unhealthy gut has an imbalance of gut bacteria. This imbalance or gut dysbiosis is linked to disorders such as inflammatory bowel disease, type 2 diabetes, high blood pressure and cancer.

Prebiotics are a group of fibers that are resistant to digestion. They help stimulate the growth and/or activity of the guts good bacteria.

A review of studies on the effects of seaweeds (including sea moss) as a whole in human, animal and in vitro (microorganisms), suggests that certain components unique to seaweeds have the potential to act as prebiotics and support gut health.The authors of the review note that while these trials show the prebiotic potential of seaweed components, large scale human clinical trials are required to validate findings.

The various nutrients in sea moss not only help build muscles and maintain muscle health but also help maintain a healthy bone structure, notes Dr. Lam. This is of much importance to those on a strict exercise regime or the elderly who tend to see a loss in muscle and bone mass due to the aging process, she says.

A small 2018 observational study looked at the effects of sea moss supplementation in 80 patients with musculoskeletal diseases and joint related symptoms. Subjects were divided into two groups treated with different sea moss supplements.

Some of the study participants from both groups reported beneficial effects such as more strength and energy and less exhaustion and pain after supplement treatment. Researchers concluded that this may be due to the high protein content in sea moss. Notably, subjects given the sea moss supplement with greater protein content had higher muscle energy recovery.

There are other potential health benefits of sea moss. However, as these benefits have only been observed in animal and in vitro studies, further clinical trials on humans are needed.

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Akasha Naturals Magnesium Glycinate promotes muscle relaxation and anti-oxidation, optimizes calcium utilization, improves nerve conduction, and offers superior absorption.

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The Health Benefits Of Sea Moss, According To Experts - Forbes

- Company will present five posters discussing REACT and chronic kidney disease during the ASN Annual Meeting, November 3 - 6, 2022

- Investor and analyst scientific briefing to be hosted in Orlando, FL on November 3, 2022

WINSTON-SALEM, N.C., Oct. 14, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (ProKidney), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that the Company will present five posters on REACT and CKD at the upcoming American Society of Nephrologys (ASN) Kidney Week being held November 3-6, 2022, in Orlando, FL.

Details for the poster presentations are as follows:

Session Title: CKD: Epidemiology, Risk Factors, Prevention I [PO2201-1]

Session Date, Time: November 3, 2022, from 10:00 AM to 12:00 PM

Poster Board #: TH-PO887

Session Title : Genetics, Development, Regeneration [PO0500]

Session Date, Time: November 4, 2022, from 10:00 AM to 12:00 PM

Poster Board #: FR-PO394

Session Title: CKD: Epidemiology, Risk Factors, Prevention II [PO2201-2]

Session Date, Time: November 4, 2022, from 10:00 AM to 12:00 PM

Poster Board #: FR-PO905

Abstracts can be accessed online at https://www.asn-online.org/education/kidneyweek/.

ProKidney also announced today that it will host an investor and analyst scientific briefing, followed by a reception, the evening of November 3, 2022, in Orlando, FL. To register for the event, or for additional information, please contact Dr. Glenn Schulman at glenn.schulman@prokidney.com. Following the event, a copy of the presentation slides will be available on the Companys website at https://investors.prokidney.com/news-events/events-and-presentations.

About ProKidney

ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidneys lead product candidate, REACT (Renal Autologous Cell Therapy), is a first-of-its-kind, patented, autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases potentially drive meaningful improvement in kidney function. Late-stage CKD patients, Stage 3b - 4, is a key target population for REACT therapy. REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program that launched in January 2022. For more information, visit http://www.prokidney.com.

About CKD

There are no therapies that effectively reverse late-stage CKD. CKD is a serious diagnosis with significant morbidity and mortality. Notably, the 5-year mortality of newly diagnosed Stage 4 CKD is higher than that of newly diagnosed non-metastatic cancer. CKD most often presents as a progressive decline in kidney function, ultimately resulting in the failure of the kidneys and the need for renal replacement therapy, such as hemodialysis or kidney transplant. One in three Americans is at risk for CKD which currently affects approximately 75 million people in the United States and Europe and over 400 million across Asia. CKD is among the largest single expenses incurred by the U.S. health care system.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. ProKidneys actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as expect, estimate, project, budget, forecast, anticipate, intend, plan, may, will, could, should, believes, predicts, potential, continue, and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the combined companys expectations with respect to financial results, future performance, development and commercialization of products, if approved, the potential benefits and impact of the combined companys products, if approved, potential regulatory approvals, anticipated financial impacts and other effects of the business combination on the combined companys business, and the size and potential growth of current or future markets for the combined companys products, if approved. Most of these factors are outside of the combined companys control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the combined companys Class A ordinary shares on the Nasdaq following the business combination; the inability to implement business plans, forecasts, and other expectations and to recognize the anticipated benefits of the business combination or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the combined company to raise financing in the future; the inability of the combined company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the combined company to identify, in-license or acquire additional technology; the inability of combined company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the combined companys products, if approved, and its ability to serve those markets, either alone or in partnership with others; the combined companys estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the combined companys financial performance; the combined companys intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the impact of COVID-19 or geo-political conflict such as the war in Ukraine on the combined companys business; and other risks and uncertainties indicated from time to time in the proxy statement relating to the business combination, including those under Risk Factors therein, and in the combined companys other filings with the Securities and Exchange Commission. The combined company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The combined company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Information

Investors & Media

Glenn Schulman, PharmD, MPH

SVP, Investor Relations

glenn.schulman@prokidney.com

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ProKidney Announces Multiple Abstracts Selected for Presentation at the American Society of ... - The Bakersfield Californian

OPTIMAL Pain & Regenerative Medicine focuses on treating patients through restorative and pain management solutions. We offer state of the art biologic treatments that have changed the way medicine is practiced today. Our practice specializes in the treatment of neck and back pain, arthritis, neuropathy, diseases, headaches, joint and soft-tissue injuries and sports related injuries.

Dr. Scott Berlin and Dr. Michael Phillips of OPTIMAL Pain & Regenerative Medicine strive to be at the forefront in providing cutting edge pain management and regenerative medicine options to the Dallas-Ft. Worth metroplex. As board certified anesthesiologists, their collective expertise includes a full range of innovative treatment options. No matter what your stage of life, OPTIMAL delivers comprehensive, current and most importantly, compassionate medical care.

To date, it is estimated that over 116 million American adults are affected by some degree of chronic pain. Pain management is important for patients who are suffering from acute, chronic and cancer pain. Pain management includes injection/interventional therapy, implantable therapies, physical therapy,medication managementand other suitable treatment options.

Regenerative medicine offers a solution to patients who have conditions that seem beyond repair. Regenerative medicine is a process of replacing the bodys owns cells, tissues or organs to restore normal function. OPTIMAL specializes in minimally invasive bone marrow aspirate concentrate (BMAC), a stem cell therapy for back pain, as well as platelet rich plasma therapy (PRP) for joints or soft tissue injuries.

To get to learn more about our practice please review our physician profiles and patient education.

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Pain Management & Regenerative Medicine Specialists DFW

Source: Northwestern University

Cells are the building blocks of tissue, and tissues are the basic unit of function in the body. Generally, groups of cells make and secrete their own support structures, called extra-cellular matrix. This matrix, or scaffold, does more than just support the cells; it also acts as a relay station for various signaling molecules. Thus, cells receive messages from many sources that become available from the local environment. Each signal can start a chain of responses that determine what happens to the cell. By understanding how individual cells respond to signals, interact with their environment, and organize into tissues and organisms, researchers have been able to manipulate these processes to mend damaged tissues or even create new ones.

The process often begins with building a scaffold from a wide set of possible sources, from proteins to plastics. Once scaffolds are created, cells with or without a cocktail of growth factors can be introduced. If the environment is right, a tissue develops. In some cases, the cells, scaffolds, and growth factors are all mixed together at once, allowing the tissue to self-assemble.

Another method to create new tissue uses an existing scaffold. The cells of a donor organ are stripped and the remaining collagen scaffold is used to grow new tissue. This process has been used to bioengineer heart, liver, lung, and kidney tissue. This approach holds great promise for using scaffolding from human tissue discarded during surgery and combining it with a patients own cells to make customized organs that would not be rejected by the immune system.

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Tissue Engineering and Regenerative Medicine - National Institute of ...

The project for the development of the International Stem Cell and Regenerative Medicine Research and Therapeutic Center in Egypt is moving forward.

Recently, the North African countrys Ministry of Defense awarded a management and supervision consultancy services contract for the project. The contract was awarded to Hill International an American construction consulting firm that provides program, project, and construction management services.

International Stem Cell and Regenerative Medicine Research and Therapeutic Center in Egypt will feature three components categorized as facilities. These will be the animal welfare facility, the bioreactor facility, and the research facility. Moreover, center staff will have the opportunity of using the new facilities. The staff will have the liberty of conducting basic and preclinical clinical trials with stem cells.

The healthcare project represents the latest effort to enrich the countrys healthcare sector. It aims to leverage the therapeutic potential of stems to develop. The development of stem cells will contribute to a major advance in regenerative medicine.Moreover, it would be a great opportunity to not just promote health and welfare in Egypt, but to the whole world as well.

Also Read:Contracts signed for UC Development projects in NAC, Egypt

The International Stem Cell and Regenerative Medicine Research and Therapeutic Center in Egypt will work in cooperation and together with industrial, non-governmental, academic as well as governmental institutions.

The CEO of Hill International spoke about the project. Raouf Ghali affirtmed that the firm will make use of its expertise to ensure the project is realized as planned. Moreover, the CEO added that the company is proud of the projects progress as it will be of great impact on the country.

Hill International boasts over 3,200 professionals in approximately 100 offices worldwide. Impressively, the ENgineering New-Record magazine ranks the firm as one of the largest construction management firms.

If you need more information on this project. Current status, project team contacts etc. Please contact us

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International Stem Cell and Regenerative Medicine Research and Therapeutic Center in Egypt - Construction Review

Media Advisory

Wednesday, August 31, 2022

At the National Institutes of Health, a surgical team successfully implanted a patch of tissue made from patient cells with the goal of treating advanced dry age-related macular degeneration (AMD), also known as geographic atrophy. Dry AMD is a leading cause of vision loss among older Americans and currently has no treatment.

The patient received the therapy as part of a clinical trial that is the first in the United States to use replacement tissues from patient-derived induced pluripotent stem (iPS) cells. The surgery was performed by Amir H. Kashani, M.D., Ph.D., associate professor of ophthalmology, Wilmer Eye Institute, Johns Hopkins School of Medicine with assistance by Shilpa Kodati, M.D., staff clinician, NEI. The procedure was performed at the NIH Clinical Center in Bethesda, Maryland, under a phase 1/2a clinical trial to determine the therapys safety.

This iPS cell derived therapy was developed by the Ocular and Stem Cell Translational Research Section team led by Kapil Bharti, Ph.D., senior investigator at the National Eye Institute (NEI), part of NIH, in collaboration with FUJIFILM Cellular Dynamics Inc., and Opsis Therapeutics, based in Madison, Wisconsin. Safety and efficacy of this cell therapy was tested by the NEI preclinical team. Clinical-grade manufacturing of this cell therapy was performed at the Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, NIH.

This surgery is the culmination of 10 years of research and development at the NEI. In the NIH lab, the patients blood cells were converted to iPS cells, which can become almost any type of cell in the body. In this case, they were programmed to become retinal pigment epithelial (RPE) cells, the type of cell that degenerates in the advanced forms of dry AMD. RPE cells nourish and support light-sensing photoreceptors in the retina. In AMD, the loss of RPE leads to the loss of photoreceptors, which causes vision loss. This work was supported by the NIH Common Fund and NEI Intramural funding.

Kapil Bharti, Ph.D., senior investigator, Ocular and Stem Cell Translational Research Section, NEI

Brian Brooks, M.D., Ph.D., chief, Ophthalmic Genetics and Visual Function Branch, NEI

To schedule interviews with Drs. Bharti and Brooks, contact NEI at neinews@nei.nih.gov

NIH launches first U.S. clinical trial of patient-derived stem cell therapy to replace and repair dying cells in retina (News release)

NIH researchers rescue photoreceptors, prevent blindness in animal models of retinal degeneration (News release)

Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated with Age-Related Macular Degeneration (Clinical trial information)

About the NEI: NEI leads the federal governments efforts to eliminate vision loss and improve quality of life through vision researchdriving innovation, fostering collaboration, expanding the vision workforce, and educating the public and key stakeholders. NEI supports basic and clinical science programs to develop sight-saving treatments and to broaden opportunities for people with vision impairment. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Excerpt from:
First U.S. patient receives autologous stem cell therapy to treat dry AMD - National Institutes of Health (.gov)

Global regenerative medicine market was valued at USD 27.29 Billion in 2020. It is expected to increase at a compound annual rate (CAGR of 11.27%) between 2021 and 2027. Tissue Engineering is the segment expected to see the greatest growth in the Global Regenerative Medicine Market. Biomaterials currently hold the largest market share in global regenerative medicine.

Regenerative medicine has the potential to treat chronic, incurable diseases such as Alzheimers disease, Parkinsons disease, diabetes, and other conditions. The Alliance for Regenerative Medicine estimates that around 1,028 clinical trials in regenerative medicine are currently underway. In 2018, regenerative medicine was funded with a total of USD 13.3 billion in global financing. The forecast period will see a significant increase in investment by market leaders in research and development of regenerative medicines.

Driving Factors

Growing prevalence of chronic diseases, genetic disorders, and cancer

Over the past few decades, the prevalence and incidence of chronic diseases like CVD, cancer and diabetes has increased dramatically around the world. Diabetes and obesity can lead to an increase in the number and complexity of wounds like infections, ulcerations (leg and foot ulcers), as well as surgical wounds. These will need treatment and may result in exorbitant medical costs.

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Restraining Factors

High cost of cell and gene therapies

The cell and gene therapies represent significant medical and scientific advancements for patients with serious and terminal illnesses. These therapies are changing the way diseases are treated and could even be cured. Injectable therapies will enable doctors and other medical professionals to infuse cells/genes through injectable methods, thereby avoiding multiple surgeries and the need for a number of drugs. Although these therapies can be life-saving and more effective than traditional treatments, demand is lower than anticipated. This is due to the high cost of these therapies as well as difficulties in obtaining coverage and reimbursements for them.

Market Key Trends

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Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN

Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.

The Seattle-based company reported it has received clearance from the FDA to initiate a Phase I study assessing ISP-001 for the treatment of Mucopolysaccharidosis type I. MPS I is a rare lysosomal storage disorder characterized by an abnormal build-up of glycosaminoglycans in the body. Immusoft aims to improve treatment of MPS 1, also known as Hurler Syndrome, with its Immune System Programming platform that uses B cells as re-dosable biofactories for therapeutic protein delivery.

Immusoft stated its platform has been designed to circumvent both immunogenicity associated with virus-delivered gene therapy, as well as chemotherapy preconditioning associated with stem cell-mediated gene therapy. Additionally, the ISP platform has been designed to enable durable therapeutic delivery and the potential to re-dose patients if necessary.

The FDA has granted ISP-001 Orphan Drug designation and Rare Pediatric Disease designation for MPS 1. The Phase I study is expected to launch later this year, the company announced.

Sean Ainsworth, chairman and CEO of Immusoft, expressed excitement over the IND clearance. He called it a huge achievement for the company and a historic moment in the field of cell and gene therapies. Current adeno-associated virus therapies and lentiviral therapies have some safety concerns. The delivery mechanism in those therapies can trigger an immune response in patients, which can limit efficacy. Stem cell treatments also have some drawbacks in some patients.

Ainsworth told BioSpacethat the companys B cell approach has been designed to overcome some of the issues that were seen in other gene therapy modalities. Building on advances made in other cell therapeutic approaches such as CAR-T therapies, Ainsworth said the company is pioneering a gene therapy approach that allows for a durable therapeutic and the potential to re-dose patients.

Our engineered B cell approach is a completely novel modality that opens potential new avenues for treating intractable diseases. Having our lead program cleared to proceed into the clinic - the first B cell approach in the clinic - broadens the potential for our platform and pipeline as we advance other programs to first-in-human studies, Ainsworth said in an email this morning.

B Cell-Focused Competition

Immusoft isnt the only company focused on the development of B cell therapies. Others include Be Biopharma and Walking Fish Therapeutics.

Paul Orchard, a professor in the division of pediatric bone marrow transplantation at the University of Minnesota Medical Center, noted that a non-viral delivery method such as ISP-001 holds promise for the treatment of some diseases, such as MPS I. He said there is a clear need for new treatments for MPS I, as current options are not curative and significant disease-related morbidity still exists.

Although there is no cure for MPS I, there are several treatment options, including hematopoietic stem cell transplant and BioMarins Aldurazyme (laronidase), an enzyme replacement therapy. However, enzyme replacement therapies require frequent infusions, which affect quality of life. Immusoft hopes its therapeutic will mitigate the need for frequent dosing and improve patient outcomes.

Other companies developing therapies for MPS I include Orchard Therapeutics and REGENXBIO.

Beyond MPS I, Immusoft has partnered with the California Institute for Regenerative Medicine on the development of a therapy for MPS II, a carbohydrate metabolism disorder.

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Immusoft Takes First-Ever Engineered B Cell Therapy into Clinic - BioSpace

Photo courtesy of Mayo

With the promise of regenerative medicine comes the risk of widening health care disparities. Sometimes the newest discoveries, such as regenerative interventions, are out of reach for people in diverse ethnic or socioeconomic groups or they may not understand or trust new options for healing.

Mayo Clinicis trying to overcome those barriers by launching community outreach and a bioethics study aimed at improving access to regenerative medicine among underserved groups.

Regenerative medicine sometimes could look like a science fiction movie. It is important to learn from the community about how things could be better explained to them or how we can erase any doubts that they have about what we do, says Jorge Mallea, M.D., a pulmonologist at Mayo Clinic in Florida. Listening to their concerns, and explaining what we know, the things still we dont have solutions for, and what we are trying to accomplish could improve understanding and engagement.

Regenerative medicine is an emerging field of practice that is shifting the focus of health care from fighting disease to rebuilding health, with an emphasis on repairing, replacing or restoring diseased cells and tissues. Mayo ClinicsCenter for Regenerative Medicineis at the vanguard of this movement, supporting the concept of regeneration for all. Dr. Mallea chairs the centers Equity, Inclusion and Diversity Advisory Committee.

More diverse clinical trials

To ensure that regenerative therapies go beyond selected or priority groups, Mayo Clinic is expanding the recruitment for clinical trials to include more diversity in race, age and socioeconomic status. For example, a dermatology study in Rochester is exploring how certain regenerative interventions might affect ethnic groups with different skin tones.

We want to learn more about diverse groups to ensure the therapies we apply would work for people of different genders, races and genetics, says Dr. Mallea. Its important to have representation from diverse groups. We could learn in our clinical trials that certain groups need different doses or distinct ways of applying the interventions.

In other research,Zubin Master, Ph.D., a bioethicist in Mayo ClinicsBiomedical Ethics Research Program, is leading a bioethics study that seeks to understand possible economic, social and ethnic barriers toplatelet-rich plasma platelets spun from a persons own blood and containing growth factors as an orthobiologic treatment for kneeosteoarthritis. Platelet-rich plasma is a new regenerative intervention that shows healing potential. However, the Food and Drug Administration has not yet approved it. Therefore, patients must pay out of pocket for it.

Mohamed Addani, aMayo Clinic Graduate School of Biomedical Sciencesstudent within Dr. Masters team, will interview patients across Mayo Clinic who choose platelet-rich plasma as an intervention for knee osteoarthritis and those who opt instead for standard care. The team will compare those responses to a more demographically diverse group of patients whove made similar care choices at Detroit Medical Center. Researchers will examine race, ethnicity, socioeconomic and demographic variables, beliefs, attitudes, and understanding of regenerative medicine.

This study will provide the first scientifically based data on whether health disparities exist among patients seeking next-generation regenerative interventions such as platelet-rich plasma, says Dr. Master. The results will give us the unique opportunity to identify factors that are creating barriers to regenerative care and proactively address ways to overcome them.

The project seeks to improve access and make regenerative medicine more equitable among diverse and underserved groups.

Showcasing the cool stuff

Attracting a more diverse pool of regenerative medicine scientists and practitioners is another strategy to boost inclusivity. Mayo Clinic is taking regenerative medicine on the road to high schools and colleges near its destination locations in Arizona, Florida and Minnesota, showcasing what Dr. Mallea describes as the cool stuff in research and development. The hope is that it might inspire students, particularly those from underrepresented and disadvantaged communities, to consider a career in regenerative medicine.

We are sharing examples of our research, such as bioprinting of organs and developing new medicines from living organisms like cells to fight different diseases and cancers, says Dr. Mallea. We hope to plant a seed in their minds that regenerative medicine holds promise not only as a future therapy, but also a future career.

In addition, Mayo is using the Community Scientist Program to open its doors to scientists from the community who want to learn more. This program pairs community scientists with regenerative medicine researchers. Mayo hopes these strategies will improve the interaction and understanding needed to ensure access to new regenerative therapies as they are introduced in the practice.

Envision yourself working for a global leader in an industry fueled by innovation and growth. Mayo Clinic has opportunities for you. Join us at Floridas No. 1 hospital by visiting https://jobs.mayoclinic.org/. For more information on health care topics please visit Mayo Clinic Jacksonville at mayoclinic.org.

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Addressing Diversity Barriers to Regenerative Medicine Free Press of Jacksonville - Jacksonville Free Press

VIKEN, Sweden, Aug. 31, 2022 /PRNewswire/ -- TikoMed, a biopharmaceutical company focused on harnessing the medical potential of the body's ability to self-repair and regenerate, today announced the publication in Frontiers in Phamacology of peer-reviewed research supporting the unique broad spectrum mechanism of action of TikoMed's ILB neuroprotective drug platform. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases, the low molecular weight dextran sulfate compound both mobilized and modulated naturally occurring tissue repair mechanisms and restored cellular homeostasis and function by releasing heparin-binding growth factors. TikoMed believes this approach to enhancing the body's self-repair and regeneration capabilities has the potential to transform current cell and gene therapy paradigms.

"These studies show that ILB releases, re-distributes and modulates the bioactivity of endogeneous heparin-binding growth factors that target disease compromised nervous tissues to initiate a cascade of transcriptional, metabolic and immunological effects that play a key role in controlling glutamate toxicity, normalising tissue bioenergetics, and resolving inflammation to improve tissue function. ILB's unique mechanism of action supports the potential to treat various acute and chronic neurodegenerative disease, including sTBI and ALS," said Ann Logan, Scientific Director at Axolotl Consulting and, Professor of Regenerative Medicine at the University of Warwick.

In summary, the studies provided evidence that ILB has a profound therapeutic effect on molecular and cellular dysfunctions causing neurodegenerative diseases. Gene expression analysis demonstrated substantial similarities in the functional dysregulation induced by severe traumatic brain injury (sTBI) and various human neurodegenerative conditions including ALS. Changes in gene expression following ILB treatment supported a cascading beneficial effect of ILB on growth factor activation resulting in the observed therapeutic effect. The transcriptional signature after ILB treatment is relevant to cell survival, inflammation, glutamate signalling, metabolism and synaptogenesis, and is consistent with the activation of neuroprotective growth factors. The ability of ILB to elevate circulating levels of heparin-binding growth factors in animal models and humans also supports its neuroprotective and regenerative effects in vivo.

Story continues

"ILB is currently being in development both as a therapeutic and as an enabling technology for advanced therapies, and this peer-reviewed research indicates even wider potential. We have initiated development programs for Amyotrophic Lateral Sclerosis (ALS), Traumatic Brain Injury (TBI) and islet cell transplantation and will now consider broader use across a wider range of diseases," said Anders Kristensson, CEO of TikoMed.

Contact: info@tikomed.com or +46 42 23 84 40

Media:

International: Richard Hayhurst richard@rhapr.eu or +44 7711 821527

Nordics: Ola Bjorkman ola.bjorkman@letemknow.se or +46 70 245 7497

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/tikomed/r/tikomed-s-ilb--mobilizes-and-modulates-key-growth-factors-that-trigger-a-cascade-of-neuroprotective-,c3623306

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LEXINGTON, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that members of its management team will participate in investor and medical conferences later this month.

A live webcast of the presentations from the HC Wainwright and Baird conferences can be accessed on the Investors & Media section of Frequencys website. A replay will be posted following the event.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also advancing a pre-clinical program for remyelination in multiple sclerosis.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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Frequency Therapeutics to Participate in September Investor and Medical Conferences - Business Wire

A new study led by the University of Oviedo in Spain has unlocked the genetic code of the immortal jellyfish, an animal capable of repeatedly reverting into a juvenile state after sexual reproduction. The experts hope that better understanding the factors leading to this creatures unique longevity could offer new perspectives on human aging.

Although many species of jellyfish have some capacity to reverse aging and revert to a larval state, most of them lose this ability once they reach sexual maturity. However, Turritopsis dohrnii appears to be the only known species able to repeatedly revert back into a larval stage even after sexual reproduction. According to the experts, the immortal jellyfish uses this superpower to avoid predators, allowing it to revert to a cyst which turns into a polyp attached to the seafloor when threaten by other animals. Once the threat is gone, the creature starts to mature once again.

To better understand what makes T. dohrnii special, the scientists sequenced its genome and compared it to that of Turritopsis rubra, a close genetic relative which lacks the capacity to rejuvenate after reaching sexual maturity. The analysis revealed that T. dohrnii had twice as many copies of the genes associated with DNA repair and protection, which helps producing greater amounts of protective and repairing proteins. Moreover, this jellyfish also had unique mutations which stunted cell division and prevented telomeres (chromosomes protective caps) from deteriorating.

Our results suggest that gene amplification and point variants unique ofT. dohrniicould affect its replicative efficiency, as well as DNA repair and telomere maintenance activity, which may be pivotal processes for cell rejuvenation and proliferation, the study authors explained.

In addition, expansions and sequence variations of genes associated with DNA repair, mitochondrial dysfunction and intercellular communication could increase its capacity to maintain redox environment and reduce cellular damage during stress events.

These findings could inspire developments in regenerative medicine and provide insights into age-related diseases such as cancer or neurodegeneration. However, as Monty Graham, a jellyfish expert and director of the Florida Institute of Oceanography put it, we cant look at it as, hey, we are going to harvest these jellyfish and turn them into a skin cream. Instead, exploring such gene variants in T. dhornii and other animals including humans could shed more light on the nature of aging, and help scientists slowly build an arsenal to combat its most unwanted effects.

The study is published in the journal Proceedings of the National Academy of Sciences.

By Andrei Ionescu, Earth.com Staff Writer

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MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing (cGMP) facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASCs team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.

We are very excited to move forward with the expansion of our cGMP facility, said Dr. David Lee, Ph.D., Head of GMP and Quality. Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry. Our unique platform of GMP-grade allogeneic iPSC and TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.

Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year.

About Applied StemCell, Inc.

ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing. With over 13 years of gene-editing and stem cell expertise, ASC offers comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTTM) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

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Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire

CAMBRIDGE, Mass., Sept. 1, 2022 /PRNewswire/ -- Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to using mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, today announced the appointment of Rainer Boehm as an independent director to its Board of Directors. Mr. Boehm will serve on Omega's audit and compensation committees.

"Rainer's growth-oriented perspective and global strategic management experience will be invaluable to Omega in this next phase of the Company's trajectory," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board for Omega Therapeutics and Founder and Chief Executive Officer of Flagship Pioneering. "I look forward to working closely with him as Omega continues to advance its clinical pipeline and demonstrate the broad capabilities of its pioneering drug development platform."

"We are thrilled to welcome Rainer to our Board and look forward to leveraging his significant drug development expertise, strategic thought-leadership and executive management skills as we work to advance our new class of programmable epigenetic medicines," said Mahesh Karande, President and Chief Executive Officer of Omega. "Rainer is a recognized industry leader with a strong track record of working with and growing innovative clinical stage companies and has extensive experience managing global drug development and commercialization."

"Omega is pioneering a new class of programmable mRNA therapeutics that have the potential to transform the way we approach difficult-to-treat diseases," said Mr. Boehm. "This is an exciting time for the Company, and I look forward to partnering with this accomplished board of directors and management team and sharing insights as they continue to pave new roads through the discovery and development of epigenomic controllers for patients in need."

Mr. Boehm brings over 30 years of clinical and managerial experience to Omega. He held several senior management positions during his extensive tenure at Novartis Pharma AG and its predecessor, CIBA-Geigy, spanning from 1988 to 2017, most recently as Chief Commercial & Medical Affairs Officer. He was a key figure in the successful establishment of Novartis Oncology. He oversaw the launch and life cycle management of many blockbuster brands in different geographies globally, amongst them Femara, Zometa and Glivec in oncology, as well as Cosentyx and Entresto and the immunology and cardiovascular disease areas. Prior to joining Novartis, he served as unit head at the Psychiatric Hospital in Zwiefalten, Germany. Mr. Boehm serves on the boards of Cellectis SA (Nasdaq: CLLS), Humanigen Inc. (Nasdaq: HGEN), BioCopy, AG (private) and Berlin Cures, AG (private). He holds a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University, Strasbourg Campus in France. Recently he commenced a Master of Public Health program at the Universities of Basel / Bern / Zurich in Switzerland.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visit omegatherapeutics.com, or follow us on Twitter and LinkedIn

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our product candidate pipeline, including our development of OTX-2002 and other drug candidates and Mr. Boehm's impact on the Company. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason BracoLifeSci Communications646.751.4361[emailprotected]

SOURCE Omega Therapeutics

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Omega Therapeutics Announces Appointment of Rainer Boehm to its Board of Directors - PR Newswire

Rise In Research And Development Projects In Various Regions Such As East Asia, South Asia Are Expected To Offer An Opportunity Of US $ 0.5 Bn In 2022-2026 Period.

Fact.MR A Market Research and Competitive Intelligence Provider: The global induced pluripotent stem cell (iPSC) market was valued at US $ 1.8 Bn in 2022, and is expected to witness a value of US $ 2.3 Bn by the end of 2026.

Moreover, historically, demand for induced pluripotent stem cells had witnessed a CAGR of 6.6%.

Rise in spending on research and development activities in various sectors such as healthcare industry is expected to drive the adoption of human Ips cell lines in various applications such as personalized medicine and precision.

Moreover, increasing scope of application of human iPSC cell lines in precision medicine and emphasis on therapeutic applications of stem cells are expected to be driving factors of iPSC market during the forecast period.

Surge in government spending and high awareness about stem cell research across various organizations are predicted to impact demand for induced pluripotent stem cells. Rising prevalence of chronic diseases and high adoption of stem cells in their treatment is expected to boost the market growth potential.

For more insights into the Market, Request Brochure of this Report

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Besides this, various cells such as neural stem cells, embryonic stem cells umbilical cord stem cells, etc. are anticipated to witness high demand in the U.S. due to surge in popularity of stem cell therapies.

Key Takeaways:

Growth Drivers:

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Many key players in the market are increasing their investments in R&D to provide offerings in stem cell therapies, which are gaining traction for the treatment of various chronic diseases.

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Human Umbilical Vein Endothelial Cells (HUVEC) Market - According to Fact.MR, the oncology segment is anticipated to accrue highly lucrative gains to the human umbilical vein endothelial cells (HUVEC) market, attributed to their purported effectiveness in targeting malignant growth. Simultaneously, uptake across tissue culture is also likely to widen in the future.

Cardiac Mapping System Market - The advent of cardiac mapping systems enabled electrophysiologists to target and treat complex arrhythmias more effectively than ever. According to the Centers for Disease Control and Prevention, more than 600,000 people die of heart disease in the United States, every year, making it essential for the medical professionals to take strong awareness initiatives to tell people about the availability of cardiac mapping technology, in a move to control the ever-growing cardiac deaths.

Cardiac Ablation Technologies Market - A surge in atrial fibrillation cases is proving to be a growth generator as cardiac ablation technology is prominently used for its treatment. Revenue across the radiofrequency segment is expected to gather considerable momentum, anticipated to account for over50%of global revenue.

Cardiac Patch Monitor Market - A cardiovascular monitor screen is a gadget that you control to record the electrical movement of your heart (ECG). This gadget is about the size of a pager. Cardiac patch monitors are utilized when you need long haul observing of side effects that happen not exactly day by day.

Cardiac Resynchronization Therapy Market - Newly-released Cardiac Resynchronization Therapy industry analysis report by Fact.MR shows that global sales of Cardiac Resynchronization Therapy in 2021 were held atUS$ 5.7 Bn. With7.9%, the projected market growth during 2022-2032 is expected to be slightly lower than the historical growth. CRT-Defibrillator is expected to be the higher revenue-generating product, accounting for an absolute dollar opportunity of nearlyUS$ 4 Bnduring 2022 2032.

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Rise In Number Of CROS In Various Regions Such As Europe Is Expected To Fuel The Growth Of Induced Pluripotent Stem Cell Market At An Impressive CAGR...

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Partnering Terms and Agreements 2015 to 2022" report has been added to ResearchAndMarkets.com's offering.

This report is intended to provide the reader with an in-depth understanding and access to Regenerative Medicine trends and structure of deals entered into by leading companies worldwide.

Regenerative Medicine Partnering Terms and Agreements includes:

In Global Regenerative Medicine Partnering Terms and Agreements 2015-2022, the available deals are listed by:

Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

The Global Regenerative Medicine Partnering terms and Agreements 2015-2022 report provides comprehensive access to available deals and contract documents for over 1600 Regenerative Medicine deals.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/pu1ymr

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Regenerative Medicine Partnering 2015 to 2022: Terms and Agreements Entered Into by the Leading Companies Worldwide - ResearchAndMarkets.com -...

A lot of people are intrigued byregenerative medicine and have heard promising information about the incredible power it has to promote healing. But theres also some confusion about what it really does and how it works.

So let's break down how and why we use these innovative therapies from head to toe and most importantly the benefits that patients see from them.

Headaches and Upper Neck Pain

Cervicogenicheadaches result from a neck issue and cause pain right below the junction of the head and neck in the cervical facet joints that allow you to turn your head side to side or forward to backwards. You may be dealing with this pain as a result of a traumatic injury, or because youre aggravated by repetitive motions like looking down and texting too much, watching TV in a poor position or having a desk set up that isnt ergonomic. Arthritis can exacerbate this problem, too.

When more traditional measures like physical therapy and massage therapy dont help, regenerative medicine can come into play. First, we usually try platelet-rich plasma (PRP) therapy, which is concentrated platelet-rich plasma protein that comes from your blood after we run it through a centrifuge to remove the red blood cells. Injecting PRP into the cervical facet joints can provide relief of acute and chronic neck pain by promoting the bodys natural healing potential. The reduction of pain combined with healing promotion can allow improvements in motion as well.

Stem cell therapy is another option. We harvest bone marrow from the pelvis and break it down to get stem cells and platelets. When we inject this into the problem area, it not only adds stem cells but also attracts more stem cells in your body at a greater rate speeding up recovery.

Both procedures change pathology and promote healing. Results can be long-term unless you injure or damage the tissue again and they can be dramaticstaving off surgery or providing a solution when surgery isnt an option.

Shoulder Pain

This most commonly presents as a rotator cuff tear and when that happens you have three options. Physical therapy helps most people get better but when it doesnt, regenerative medicine is an option if the tear affects 75 percent or less of the shoulder. If the tear is too extreme, surgery is needed.

Platelet rich plasma or PRP is the most commonly used regenerative medicine option for this injury. Its a non-operative solution that utilizes the bodys natural healing process. PRP therapy is a concentration of the patients own blood plasma injected into damaged ligaments, tendons, and joints to promote tissue repair and accelerate healing. It is rich in growth and healing factors and on average, an injured patient can get back to a pain-free life in four to six weeks.

This is a great option for shoulder injuries because most people are looking to avoid shoulder surgery given the risks and recovery.

Back Pain

Lowerback pain is the No. 1 reason people come to see me for regenerative treatment options, but this can be used to treat upper and mid-back pain too.

Regenerative medicine can help with facet joint issues, disc related pain, degeneration, a tear in disc space or irritated nerves (which can be a result of stenosis, nerve injury, surgery, etc.).

Platelet-rich plasma (PRP) therapy and stem cell therapy are both options to treat these conditions. The one we choose generally depends on individual factors with patients and their pain. The wonderful news is 100 percent improvement is possible but I should stress these therapies dont work well in the most severe cases, which likely still require surgery.

Hip Pain

The most typical cause of this pain is osteoarthritis in thehip joint but labral tears are common, too, especially among athletes.The type of treatment we opt for in the case of hip arthritis depends on how much narrowing of the joint is at play. Our top options include platelet-rich plasma (PRP) therapy and stem cell therapy.

Another option we havent yet discussed is lipoaspirate prolotherapy or adipose-derived stem cell therapy. These are also injections like PRP and stem cell therapybut they involve micro fragmented fat. We take fat from the belly and break it down to a thin paste and place it in a joint to provide cushioning and start the healing cycle. This procedure can be used for any joint hip, knee, shoulder or ankle.

Knee Pain

This is the second most common cause of pain that brings people to me for treatment (after lower back pain). The most typical triggers are arthritis but we also see a lot of meniscus and ACL tears too. PRP therapy, stem cell therapy and lipoaspirate prolotherapy are all options for this joint. But heres what you need to know withknee pain, because I know it can be concerning when it happens it is absolutely possible to heal this injury and get back to a place where you can limit and manage the problems.

Regenerative medicine makes that possible. Plenty of people come in with a meniscus tear and have been told they need surgery. Instead, we treat the tear with one of these options and have seen up to 100 percent relief. Many patients never end up in an OR, which is the goal.

It happens most often when the damage isnt too severe which is all the more reason to seek advice and help early in your pain cycle rather than waiting too long.

Ankle Pain

Treatingankle pain can be a bit trickier than other sources because we need to make sure ligaments of the ankle are intact. We can use regenerative medicine to treat both the ankle joint and the ligaments around it depending on the problem, which is generally caused by arthritis or an ankle injury maybe from rolling it.

Treatment options include PRP therapy and stem cell therapy. We have the option of using lipoaspirate prolotherapy as well when were targeting the ankle joint. One thing I havent mentioned previously is that sometimes we tap into more than one healing treatment. Its not unusual that we combine regenerative medicine therapies to accelerate healing.

Although we expect to complete the treatment one time, there are times when we also repeat the procedure to extend the benefit duration to include other nearby structures, or patients that request the procedure be repeated to continue avoiding surgery.

Regenerative medicinewhen done right, by a professionaltruly does have the ability to help you from head to toe and get you "back" to a pain-free, healthy life.

The content on 30Seconds.com is for informational and entertainment purposes only, and should not be considered medical advice. The information on this site should not be used to diagnose or treat a health problem or disease, and is not a substitute for professional care. Always consult your personal healthcare provider. The opinions or views expressed on 30Seconds.com do not necessarily represent those of 30Seconds or any of its employees, corporate partners or affiliates.

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Pain Relief Treatments: The Benefits of Regenerative Medicine From Head to Toe - 30Seconds.com

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022,1which provides that the agency plans to issue 18 guidance documents in 2022, including eight guidance documents on tissues and advanced therapies. In this alert, we highlight some key considerations from three draft guidance documents on human gene therapy products that incorporate gene editing (GE) components, chimeric antigen receptor (CAR) T cell products, and regenerative medicine therapies that can benefit biopharmaceutical developers and sponsors. Recognizing the challenges of developing such complex, multi-component biologic drug products, including unanticipated risks associated with on-target and off-target activities, these draft guidance documents describe the FDA's recommendations for preclinical and clinical testing, chemistry, manufacturing, and controls (CMC), as well as information that should be included in investigational new drug (IND) applications to ensure proper identity, potency/strength, quality, and purity of the investigational drug products. FDA recommends sponsors of such complex products to communicate with the Office of Tissues and Advanced Therapies (OTAT) in CBER early in product development before submission of an IND, to discuss the product-specific considerations in preparation for transitioning to the clinical phase.

FDA expects detailed information and data IND applications before sponsors can transition to clinical testing. We recommend biopharmaceutical developers and sponsors review the applicable FDA draft guidance documents early in their product development process to identify these needs. Work closely with both FDA regulatory counsel and intellectual property/patent counsel to ensure there is sufficient data to support an IND application, including adequate testing and quality control measures, and that CMC, preclinical, and clinical development plans are coordinated with intellectual property and patent strategies to ensure robust protection of their intellectual property and to maximize the benefits of their patents and FDA regulatory exclusivities. We also encourage interested persons to submit comments to shape the policies proposed in FDA's draft guidance documents prior to finalization.

Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing2

Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products3

Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies4

Stakeholders have until September 14, 2022, to submit comments to this draft guidance to ensure they are considered by FDA before finalization of the guidance.

For More Information

For questions regarding FDA strategy, approval, and regulatory compliance, please contact any member of Wilson Sonsini'sFDA regulatory, healthcare, and consumer productspractice. For questions regarding intellectual property and patent counseling, please contact any member of Wilson Sonsini'spatents and innovationspractice.

Andrea Chamblee,Paul Gadiock, andEva Yincontributed to the preparation of this Wilson Sonsini Alert.

[1] FDA, Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022 (Updated June 2022), available at https://www.fda.gov/media/120341/download.

[2] FDA, Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing (March 2022), available at https://www.fda.gov/media/156894/download.

[3] FDA, Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, available at https://www.fda.gov/media/156896/download.

[4] FDA, Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (June 2022), available at https://www.fda.gov/media/159237/download.

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FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products - Wilson Sonsini Goodrich...

image:The ARDD Meeting 2022 will be hosted on August 29 - September 2, 2022 view more

Credit: Insilico Medicine Hong Kong Limited

August 18, 2022 Marco Quarta, Ph.D., will present the latest research on the topic From Single Cell AI-enabled Discovery of Cellular Senescence to Targeted Senolytic Drug Development at the worlds largest annual Aging Research and Drug Discovery conference (9th ARDD). Dr. Quarta is the CEO and Co-founder at Rubedo Life Sciences.

Marco co-founded and leads Rubedo Life Sciences driving its mission to develop treatments for age-related diseases and extend healthspan by selectively targeting pathological cells involved in the biological aging process. As a scientist, he earned a Masters degree in Biotechnology, a PhD in Neuroscience, and post-doctoral training in Aging and Stem Cells Biology in the lab of his mentor Prof. Thomas Rando at Stanford University School of Medicine. He then directed at Stanford/VA Hospital Palo Alto a research team focused on translational medical research in the fields of aging and regenerative medicine. He is backed by over 20 years of research with a track record of scientific publications in top tier journals. Marco is an inventor and entrepreneur, he co-founded and led the international biotech umbrella organization Young European Biotech Network (YEBN), and later joined the European Federation of Biotechnology (EFB) executive board.

Marco Quarta founded and led the biotech company WetWare Concepts in Europe. In California, with the Stanford colleague Prof. Vittorio Sebastiano he also co-founded Turn Biotechnologies based on their work on epigenetic reprogramming of cellular aging, where he served as CSO and he is a Board Director. Quarta sits on the advisory board of the California Institute for Regenerative Medicine (CIRM) Calpoly program in regenerative medicine. He is in the advisory and research board at the Center for Healthcare Innovation (CHI). He is a member of the Paul F Glenn Center for the Biology of Aging Studies at Stanford University. Quarta keeps fostering and championing high standards of compliance, ethics and patient safety in the development of innovative translational therapeutics, putting patients and society at the center of all actions.

The conference proceedings of the ARDD are commonly published in peer-reviewed journals with the talks openly available at http://www.agingpharma.org. Please review the conference proceedings for 2019, 2020 and 2021https://www.aging-us.com/article/203859/text .

Aging is emerging as a druggable condition with multiple pharmaceuticals able to alter the pace of aging in model organisms. The ARDD brings together all levels of the field to discuss the most pressing obstacles in our attempt to find efficacious interventions and molecules to target aging. The 2022 conference is the best yet with top level speakers from around the globe. Im extremely excited to be able to meet them in person at the University of Copenhagen in late summer. said Morten Scheibye-Knudsen, MD, Ph.D., University of Copenhagen.

Aging research is growing faster than ever on both academia and industry fronts. The ARDD meeting unites experts from different fields and backgrounds, sharing with us their latest groundbreaking research and developments. Our last ARDD meeting took place both offline and online, and it was a great success. I am particularly excited that being a part of the ARDD2022 meeting will provide an amazing opportunity for young scientists presenting their own work as well as meeting the experts in the field. said Daniela Bakula, Ph.D., University of Copenhagen.

Many credible biopharmaceutical companies are now prioritized aging research for early-stage discovery or therapeutic pipeline development. It is only logical to prioritize therapeutic targets that are important in both aging and age-associated diseases. The patient benefits either way. The best place to learn about these targets is ARDD, which we organize for nine years in a row. This conference is now the largest in the field and is not to be missed, said Alex Zhavoronkov, Ph.D., founder and CEO of Insilico Medicine and Deep Longevity.

Building on the success of the ARDD conferences, the organizers developed the Longevity Medicine course series with some of the courses offered free of charge at Longevity.Degree covered in the recent Lanced Healthy Longevity paper titled Longevity medicine: upskilling the physicians of tomorrow.

About Aging Research for Drug Discovery Conference

At ARDD, leaders in the aging, longevity, and drug discovery field will describe the latest progress in the molecular, cellular and organismal basis of aging and the search for interventions. Furthermore, the meeting will include opinion leaders in AI to discuss the latest advances of this technology in the biopharmaceutical sector and how this can be applied to interventions. Notably, this year we are expanding with a workshop specifically for physicians where the leading-edge knowledge of clinical interventions for healthy longevity will be described. ARRD intends to bridge clinical, academic and commercial research and foster collaborations that will result in practical solutions to one of humanity's most challenging problems: aging. Our quest? To extend the healthy lifespan of everyone on the planet.

About Scheibye-Knudsen Lab

In the Scheibye-Knudsen lab we use in silico, in vitro and in vivo models to understand the cellular and organismal consequences of DNA damage with the aim of developing interventions. We have discovered that DNA damage leads to changes in certain metabolites and that replenishment of these molecules may alter the rate of aging in model organisms. These findings suggest that normal aging and age-associated diseases may be malleable to similar interventions. The hope is to develop interventions that will allow everyone to live healthier, happier and more productive lives.

About Deep Longevity

Deep Longevity has been acquired by Edurance RP (SEHK:0575.HK), a publicly-traded company. Deep Longevity is developing explainable artificial intelligence systems to track the rate of aging at the molecular, cellular, tissue, organ, system, physiological, and psychological levels. It is also developing systems for the emerging field of longevity medicine enabling physicians to make better decisions on the interventions that may slow down, or reverse the aging processes. Deep Longevity developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed "deep aging clocks" to provide a universal multifactorial measure of human biological age. Originally incubated by Insilico Medicine, Deep Longevity started its independent journey in 2020 after securing a round of funding from the most credible venture capitalists specializing in biotechnology, longevity, and artificial intelligence. ETP Ventures, Human Longevity and Performance Impact Venture Fund, BOLD Capital Partners, Longevity Vision Fund, LongeVC, co-founder of Oculus, Michael Antonov, and other expert AI and biotechnology investors supported the company. Deep Longevity established a research partnership with one of the most prominent longevity organizations, Human Longevity, Inc. to provide a range of aging clocks to the network of advanced physicians and researchers. https://longevity.ai/

About Endurance RP (SEHK:0575.HK)

Endurance RP is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering. https://www.endurancerp.com/

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Marco Quarta to present at the 9th Aging Research & Drug Discovery Meeting 2022 - EurekAlert