Phase 1 Trial Assessing Stem Cell Therapy Recruiting Alzheimer’s Patients in Florida

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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A Phase 1 trial to evaluate the safety and effectiveness of Longeveron’s allogeneic mesenchymal stem cells (LMSCs) in patients with Alzheimer’s disease is currently looking for participants, the biopharmaceutical company announced.

Eligible participants must be between 50 and 80 years old, with a confirmed diagnosis of Alzheimer’s disease in accordance with established criteria from the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association. Additionally, participants are required to have an identified adult caregiver.

The randomized, double-blinded trial (NCT02600130) will take place in the U.S. at three centers in South Florida, two of them with open recruitment — Brain Matters Research in Delray Beach and the University of Miami Miller School of Medicine in Miami — and Miami Jewish Health Systems, which is not yet recruiting.

Information on enrollment is available on the trial’s official page.

Researchers are aiming to recruit 30 participants who will be randomized to one of three groups — low-dose LMSCs, high-dose LMSCs, or placebo (control).

Participants in the low-dose LMSCs group will receive 20 million LMSCs, the high-dose LMSCs group will get 100 million, and the placebo group will be treated with a solution (plasmalyte A and 1% human serum albumin) that mimics human plasma (the liquid component of the human blood). LMSCs are delivered directly into the vein.

“Alzheimer’s disease is one of the most pressing healthcare issues for aging individuals, and we need an effective treatment, if not a cure. An innovative study such as the Longeveron stem cell clinical trial is an important and promising step forward,” Marc Agronin, MD, geriatric psychiatrist and vice president of Behavioral Health and Clinical Research at Miami Jewish Health, said in a press release.

Longeveron’s MSCs are derived from the bone marrow of young, healthy donors. In a Phase 1 (NCT02065245) trial followed by a Phase 2 trial with frail patients, the therapy was shown to improve patients’ physical performance measures, lung function, and inflammatory biomarkers.

“Regenerative medicine is the future. Controlling inflammation in Alzheimer’s disease is the key to a breakthrough,” said Mark Brody, MD, of Brain Matters Research.

In April 2018, a stem cell therapy developed by two South Korea-based biotechs, called Nature Cell and Biostar Stem Cell Research Institute, received — for the first time anywhere — regulatory approval and was made commercially available in Japan. The therapy is available to treat mild to moderate Alzheimer’s disease.