MIAMI – A clinical trial for a sophisticated stem cell therapy for Alzheimer’s patients will soon be underway at Miami Jewish Health.
Longeveron LLC, a biopharmaceutical company that develops stem cell therapies for age-related diseases, is currently seeking up to 30 participants for the randomized, placebo-controlled, doubled-blinded trial.
Stem cell therapy is a procedure in which new cells are introduced directly into an injured area or joint, promoting healing and growth. The multitude of administered cells allows the body to proceed with the healing process at an accelerated rate.
“What makes Alzheimer’s disease so devastating is the destruction of neurons due to several toxic proteins,” explained Marc E. Agronin, M.D., vice president of clinical research and behavioral health at Miami Jewish Health. “Most of the existing clinical trials attempt to address these proteins without having a way to replace or rejuvenate damaged cells. This clinical trial attempts to replace the cells themselves and holds the promise for rebuilding what was damaged.”
Eligible participants should be between 50 and 80 years old, be diagnosed with Alzheimer’s disease and have an identified caregiver. Longeveron’s research is supported by the Alzheimer’s Association Part the Cloud Challenge on neuroinflammation.
Clinical trials are nothing new to Miami Jewish Health. At any time, there are a dozen or so trials in progress here.
Recently, Miami Jewish Health was also the site of clinical trial for an experimental drug that has slowed the memory decline associated with Alzheimer’s disease. The success of the drug, from Biogen and Japanese partner Esai, was announced in July 2018 at the Alzheimer’s Association International Conference in Chicago.
A clinical trial for that drug took place at Miami Jewish Health from April 2013-March 2018.
Clinical Trial for Stem Cell Therapy Offers Alzheimer’s Patients Hope
The stem cell therapy targets Alzheimer’s disease from a different angle.
“This study is one of the most cutting edge approaches to Alzheimer’s disease in existence now. It’s trying to get at the most fundamental issue which is the loss of brain cells,” Agronin said. “We are very proud at Miami Jewish Health to be on this forefront as we have been in the past with other kinds of Alzheimer’s studies.”
Ricardo Castañeda, Miami Jewish Health’s director of clinical research and business development, said the new clinical trial provides options.
“First and foremost, this is cutting edge in therapy. For a lot of diseases, not just Alzheimer’s disease, the use of stem cells could potentially provide some kind of benefit to these patients,” Castañeda said. “This is another alternative for folks who are dealing with the disease. It provides hope.”
Miami Jewish Health Offers Variety of Dementia-Related Clinical Trials
Longeveron’s MSC product is derived from the bone marrow of young, healthy donors and is currently being tested in a variety of indications in clinical trials, including Aging Frailty. In 2017, the company published positive Phase I and Phase 2 Aging Frailty study results in the Journals of Gerontology. Frail patients showed marked improvement in physical performance, lung function and inflammation biomarkers, with no serious adverse effects attributed to the treatment, according to a news release.
“This is something new that is being done at Miami Jewish,” Castañeda said. “The therapy is the latest therapeutical alternative for Alzheimer’s disease and both Miami Jewish Health and Longeveron are hopeful that this will yield positive results for the people in these trials.
Agronin said patients with Alzheimer’s disease can’t afford to be complacent.
“Alzheimer’s is a moving target. The opportunities tend to slip away,” he said. “”These tend to be very safe studies and you have 24/7 access by cell phone to a nationally-known geriatric psychiatrist.”
He added, “I always make the point that you can go to any major center in the country doing bench research in Alzheimer’s disease but if you want the latest and greatest practical approaches in research studies we are doing them all here.”
To find out if you or a loved one qualifies, call Miami Jewish Health’s Research Hotline at 305-514-8710.