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Stem cell therapy success in early trial to treat Parkinson’s disease | PET – BioNews

A stem cell-based therapy for Parkinson's disease entered higher dose clinical testing after a positive initial safety evaluation.

STEM-PD uses human pluripotent stem cells that have been programmed to develop into dopamine nerve cells, which produce a chemical called dopamine that helps to control body movement. The stem cells are then transplanted into the brains of Parkinson's disease patients to replace cells that are lost during the course of the disease and to repair the damage caused. Current drugs, such as levodopa, only temporarily replace dopamine, but do not target the underlying disease.

'The vision is that it could be given as a one-time treatment and the hope is that the patients can reduce their medication, avoid side effects of the drug treatment and get a long-term good motor effect from the cells for life," Dr Gesine Paul-Visse, principal investigator from Lund University and Skne University Hospital, both in Sweden, said.

The method of growing transplantable dopamine cells from stem cells was initially developed by scientists at Lund University. The trial is now a collaboration between Lund University, Skne University Hospital, the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, and Imperial College London.

The human pluripotent stem cells used for generating the STEM-PD product are obtained from human embryonic stem cells, grown in the laboratory from a surplus embryo from IVF. The cells are then transplanted into a specific area of the patient's brain that is involved in motor control. After a few months, they start sending out nerve fibres and producing dopamine.

STEM-PD has already been shown to be safe and effective at reverting motor deficits in animal models of Parkinson's disease, and entered a first-in-human clinical trial in February 2023 at Skne University Hospital (see BioNews 1164).

An initial four patients were injected with a lower dose of seven million cells, with the team reporting no concerning side effects from the therapy. Furthermore, imaging of the patient brains 6-12 months' post transplantation showed signs of dopamine cell survival. Yet, the team cautions that it is still too early to evaluate the clinical effects of the transplanted stem cells.

The first patient to receive the stem cell therapy a year ago, Thomas Matsson, was diagnosed with Parkinson's disease when he was 42. He can now move freely again and has regained his sense of smell: 'I've reduced my medication for Parkinson's. Before, everything was slow and everything was difficult I do long-distance skating, slalom, cross-country skiing, padel tennis, and, above all, golf,' he said.

Now, a further patient has been injected with a higher dose of 14 million cells, with a further three patients to be treated in 2024. The primary objective of this trial is to assess the safety and tolerability of the therapy after one year, however, the patients will be monitored for three years with a secondary objective to evaluate the clinical efficacy of the therapy.

'There is absolutely hope. Absolutely there is!', added Dr Paul-Visse.

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Stem cell therapy success in early trial to treat Parkinson's disease | PET - BioNews

How to help the public navigate stem cell products – Baylor College of Medicine Blog Network – Baylor College of Medicine | BCM

Society is aging. According to the U.S. Census Bureau, the number of Americans 65 and older is projected to increase from 58 million in 2022 to 82 million by 2050 (a 47% increase), and the 65-and-older age groups share of the total population is projected to rise from 17% to 23%.

As this transition occurs, more and more people will struggle with aches and pains. The frequency of pain in community-dwelling older adults is reported to be as high as 73%. This pain can be related to acute situations (illness and falls) or chronic conditions (arthritis, long-term outcomes from sports injuries, etc.). Regardless of the cause of pain, more and more individuals are seeking non-opioid and non-medicinal approaches to pain management. Current approaches include yoga, exercise, acupuncture, diet changes and, interestingly, stem cell therapy.

For pain sufferers, promising treatments for joint pain and arthritis derived from their own blood or adipose tissue seem miraculous. Such treatments with stem cells are becoming increasingly possible. Pluripotent stem cells are capable of self-renewing and can differentiate into specialized cell types such as blood, bone, cartilage, muscle and even organs.

While there are some legitimate clinical trials to determine if stem cells can help decrease pain or even help repair damaged tissue, there are currently no FDA-approved stem cell products for arthritis or joint pain. Without FDA approval, these products arent known to be safe or efficacious.

For desperate pain sufferers, this can mean that they seek treatment with unapproved and unproven stem cell products. Unfortunately, patients frequently obtain such products through direct-to-consumer advertising. Unapproved and unproven products can be expensive (for example, the average cost is $3,000 $5,000 per injection per knee). They can also be dangerous, not only causing possible local damage but also potentially transmitting infections and diseases.

Unfortunately, pain isnt the only indication for which these clinics and providers use direct-to-consumer advertising to motivate the public to try their unapproved and unproven stem cell products. The products are being used for many other indications, including cosmetic procedures, heart disease, glaucoma and dementia.

The FDA has tried diligently to control the spread of these unethical stem cell clinics through both regulatory actions and direct public education. However, some patients have already been injured by these unapproved and unproven products.

One of the best ways that healthcare providers can help combat the use of unapproved and unproven stem cell therapies is by providing truthful information to patients.

The International Society for Cell and Gene Therapy (ISCT) published a guide for healthcare providers to help them as they educate their patients about stem cells. The guide was developed to help identify and distinguish safe and approved cell and gene therapy products from those that do not have a proven record of safety and efficacy.

As we navigate the complex world of stem cell therapy, its crucial to stay informed and empowered. If you or a loved one are considering stem cell therapy, dont hesitate to consult with a healthcare provider who prioritizes safety and adheres to guidelines set forth by reputable organizations like ISCT. Together, lets ensure that our journey toward medical advancements is as safe as it is promising.

By Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development in the Center for Cell and Gene Therapy and professor of Pediatrics at Baylor College of Medicine

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How to help the public navigate stem cell products - Baylor College of Medicine Blog Network - Baylor College of Medicine | BCM

City of Hope Awarded $5.4 Million CIRM Grant to Create a Stem Cell Laboratory and Expand Access to State-of-the-Art … – Elk Valley Times

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City of Hope Awarded $5.4 Million CIRM Grant to Create a Stem Cell Laboratory and Expand Access to State-of-the-Art ... - Elk Valley Times

Tevogen Bio Appoints Former Police Chief & FBI National Academy Graduate, William Keane, as Vice President of Strategic Initiatives

WARREN, N.J., May 16, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, announces the appointment of William Keane as Vice President of Strategic Initiatives.

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Tevogen Bio Appoints Former Police Chief & FBI National Academy Graduate, William Keane, as Vice President of Strategic Initiatives

Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH

Daix (France), Long Island City (New York, United States), May 16, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today announced the positive recommendation from the fourth scheduled meeting of the Data Monitoring Committee (“DMC”) to continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients with MASH/NASH without modification to the current trial protocol.

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Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH

Harvard Bioscience, Inc. to Participate in the Benchmark Healthcare House Call Virtual Conference

HOLLISTON, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (Nasdaq: HBIO) today announced that Jim Green, Chairman and Chief Executive Officer, and Jennifer Cote, Chief Financial Officer, will be participating in the Benchmark Healthcare House Call Virtual Conference on May 22nd, 2024, with a live fireside chat scheduled for 9:00-9:40 am ET. The Company will also be hosting one-on-one meetings with investors in conjunction with the Conference.

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Harvard Bioscience, Inc. to Participate in the Benchmark Healthcare House Call Virtual Conference

Spero Therapeutics to Participate in H.C. Wainwright Annual BioConnect Investor Conference

CAMBRIDGE, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Sath Shukla, President and Chief Executive Officer of Spero Therapeutics, will participate in a fireside chat and be available for one-on-one meetings at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ, to take place on Monday, May 20, 2024, at the NASDAQ World Headquarters New York, NY. Details are as follows:

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Spero Therapeutics to Participate in H.C. Wainwright Annual BioConnect Investor Conference