Miami VA Clinical Site Joins Phase 2 Lomecel-B Clinical Trial
A Miami Veterans Affairs (VA) clinical site is now part of Longeveron’s Phase 2a clinical trial testing Lomecel-B — an investigational, bone marrow-derived, medicinal signaling cell (MSC) treatment — in patients with mild Alzheimer’s disease.
The new clinical site was added following a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs.
“After meeting the rigorous requirements of the VA, we are pleased to announce the addition of this particular Miami VA site to our ongoing trial,” Geoff Green, CEO at Longeveron, said in a press release.
Lomecel-B MSCs are stem cells derived from the bone marrow of healthy adult donors. This type of cell has been shown to promote tissue’s natural repair, to contribute to organ maintenance and to the function of the immune system.
Longeveron believes Lomecel-B can reduce several hallmarks of Alzheimer’s — including brain inflammation and damage, while promoting regenerative responses — and improve blood vessel function.
The CLEAR MIND Phase 2a trial (NCT05233774) aims to assess how safe and tolerable Lomecel-B is. Additional goals include assessing changes in cognitive function and disease biomarkers.
Participants will be randomly assigned to a placebo (group 1) or one of three groups of Lomecel-B — a single dose of 25 million cells followed by three placebo infusions (group 2), four doses of 25 million cells (group 3), or four doses of 100 million cells (group 4). The treatment is delivered as an intravenous (into-the-vein) infusion.
The trial seeks to enroll 48 patients, ages 60 to 85 years old, with mild Alzheimer’s (12 patients per group). Enrollment is ongoing and more information is available here.
The trial follows a prior Phase 1 study (NCT02600130) that showed Lomecel-B was safe and well tolerated in people with mild Alzheimer’s. The treatment slowed cognitive decline and boosted quality of life relative to a placebo, while increasing the levels of several biomarkers for generating new blood vessels. Anti-inflammatory markers were also significantly increased after Lomecel-B treatment.
This is the third separate CRADA agreement between Longeveron and the VA.
“This continued collaboration between Longeveron and the Miami VA reflects our ongoing efforts to develop a safe and effective cell-based therapy for this devastating disease in the vital setting of the VA health system,” Green said.
Jorge G. Ruiz, MD, the associate director of the VA’s Department of Geriatric Research Education and Clinical Center (GRECC) will be the researcher leading the trial at the Miami VA.
“The Miami VA Healthcare System GRECC is, once again, pleased to be partnering with Longeveron on another important study,” Ruiz said. “We share the goal of caring for our Veteran’s with Alzheimer’s disease, which is affecting many older Veterans and the overall older population.”
The VA Miami Healthcare System provides care to around 63,000 Veterans in three south Florida counties – Miami-Dade, Broward, and Monroe.
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