Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease

Sponsor
University Hospital, Toulouse
Study ID
NCT07367815
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • CellREADY® drug product IV dose of 50 millions — DRUG
    Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50 millions. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the "100x106 AdMSC " group will only start after the 6-month follow-up and safety analysis completed in the "50x106 AdMSC " group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.
  • CellREADY® drug product IV dose of 100 millions — DRUG
    Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 100 millions. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the "100x106 AdMSC " group will only start after the 6-month follow-up and safety analysis completed in the "50x106 AdMSC " group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.
  • cerebral RMI — DIAGNOSTIC_TEST
    cerebral RMI at V1, V5 and V6
  • PET scan — DIAGNOSTIC_TEST
    amyloïde PET scan (flutémétamol) at V1 and V6

Study Details

A3D is a phase I/II clinical trial. The primary objective is to evaluate the safety of allogeneic adipose tissue derived-stem cells (AdMSC) administered by intravenous (IV) route in mild to moderate Alzheimer disease (AD) using a dose escalation protocol.

Key Dates

First listed
Jan 26, 2026
Start date
May 7, 2026
Status verified
Jun 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 50 millions AdMSC dose
    Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50x106 or 100x106 AdMSC (from 3 to 6 patients, "50x106 AdMSC " group, group 1)
  • Experimental: 100 millions AdMSc dose
    Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50x106 or 100x106 AdMSC (from 3 to 6 patients, "100x106 AdMSC " group, group 2) if safety analysis of group 1 is correct.

Primary Outcome Measure

number of participants in each group with a clinically significant serious or non-serious AE related to treatment [ Time Frame: 6 months ]

Central Contacts

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