A Phase, I Prospective, Randomized, Double-Blinded, Placebo-controlled, Trial to Evaluate the Safety and Potential Efficacy of Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease

NCT02600130 Phase 1 COMPLETED

This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the treatment of subjects with clinically diagnosed Alzheimer's disease.

Details

Lead sponsor	Longeveron Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	2016-10-10
Completion	2021-09

Conditions

• Alzheimer's Disease

Interventions

• Longeveron Mesenchymal Stem Cells
• Placebo

Primary outcomes

• To demonstrate the safety of LMSCs administered to subjects with Alzheimer's disease. — 30 days post infusion
  Incidence of any treatment-emergent serious adverse event (TE-SAE), defined as one or more of the following untoward medical occurrences happening within the first 30 days after infusion. * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Results in death. * Leads to other clinically significant untoward laboratory test result(s) or medical condition(s), determined per Investigator's judgement (e.g., new clinically asymptomatic brain microhemorrhages).

Countries

United States