Longeveron Gets $3M Alzheimer’s Association Grant to Continue Stem Cell Study

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by Mary Chapman |

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Biopharmaceutical company Longeveron will use a $3 million Alzheimer’s Association grant to advance innovative research that uses adult stem cells to target neuroinflammation in people with mild Alzheimer’s disease (AD).

Funding is through the organization’s Part the Cloud global research grant program, designed to find promising targets for new Alzheimer’s treatments. The program supports early-stage clinical investigations with the goal of slowing, stopping, or impeding Alzheimer’s progression. It originally gave Longeveron $1 million for two years of study.

Longeveron’s initial grant was one of four awarded through the Part the Cloud Challenge on Neuroinflammation, created to deepen understanding of neurodegeneration in diseases such as Alzheimer’s. The challenge’s goal is to accelerate therapeutics for use in early clinical trials.

Now, the project by Anthony Andrew Oliva, PhD, and his colleagues, has been chosen as the most outstanding of the four. The researchers were awarded the additional funding “to take their project and the field to the next level,” the association said.

“The Part the Cloud grants provide the necessary funding for high risk, but highly promising early-stage research that the Alzheimer’s Association is committed to advancing,” Maria C. Carrillo, PhD, chief science officer of the Alzheimer’s Association, said a press release. “We are excited to support Longeveron’s innovative clinical trial because we need these types of trials, to find better preventions and treatments for Alzheimer’s.”

Miami-based Longeveron began recruiting last June for a Phase 1 trial (NCT02600130) to test the safety and effectiveness of its allogeneic mesenchymal stem cells (LMSCs) therapy. These stem cells are derived from the bone marrow of young, healthy adult donors. The randomized double-blinded investigation involves some 30 participants at four Florida trial sites, including Brain Matters Research in Delray Beach, the University of Miami Miller School of Medicine, Miami Jewish Health Systems, and The Neurology Group in Kendall.

Eligible participants must have an identified adult caregiver, and be between ages 50 and 80. Further, they must have a confirmed diagnosis of AD in accordance with set criteria from the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association. Visit this site for more enrollment information.

Enrollees will be randomly selected to one of three groups: low-dose LMSCs, high-dose LMSCs, or placebo. Those in the low-dose group will get 20 million LMSCs, while the high-dose group will receive 100 million. The placebo group will be administered a solution that mimics human plasma. The treatments will be delivered intravenously, or into the vein.

“We have seen in our Aging Frailty clinical trials the potential of stem cells to reduce inflammation, which has been identified as a potential factor in the progression and acuity of Alzheimer’s disease,” said Geoff Green, Longeveron president. “We are honored to be named as a recipient and would not be as far along in our Alzheimer’s stem cell clinical research without this major support from the Alzheimer’s Association.”

A Phase 1 trial (NCT02065245), followed by a Phase 2 trial with frail patients showed improvement in participants’ physical performance measures, lung function, and inflammatory biomarkers.

Led by Oliva, the newly funded LMSC trial is designed to make neurological, neurocognitive, and quality-of-life assessments. It also will evaluate blood and cerebrospinal inflammatory biomarkers, as well as Alzheimer’s biomarkers tau and beta-amyloid. Chronic brain inflammation may be a chief cause of Alzheimer’s and related disorders, scientists believe.

“We are hopeful that our research in degenerative medicine will show that controlling inflammation and other disease facets holds a critical key to a breakthrough in ameliorating the devastating effects of Alzheimer’s,” Oliva said.

Oliva presented a scientific poster on the investigation’s progress at this year’s Alzheimer’s Association International Conference, held recently in Los Angeles.