Stem Cells + Monoclonal Antibodies for Alzheimer's Disease

ME
Overseen ByMaria E. Puertas
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bernard (Barry) Baumel
Must be taking: Monoclonal antibodies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.

Who Is on the Research Team?

BS

Bernard S. Baumel, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

I have mild Alzheimer's and have been on Leqembi or Kisunla for at least 6 months.
* MMSE score 20-26.
* Patients must be able to consent.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one infusion of 25 million human mesenchymal stem cells in addition to standard of care monoclonal antibodies

48 weeks
Infusion at baseline, follow-up assessments at Week 16, Week 32, and Week 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Human Mesenchymal Stem Cells
  • Monoclonal Antibodies

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mesenchymal Stem Cell InfusionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bernard (Barry) Baumel

Lead Sponsor

Trials
2
Recruited
10+