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Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease

ConditionAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient between 50 and 85 years old

CDR (clinical dementia rating) score ≥ 1

Patient with no absolute contraindications for PET or MRI scans

Consent signed by the patient and study partner

Disqualifiers

Brain disease (other than AD) that may cause dementia

Presence of concomitant pathologies not permitting participation in the study

Concurrent participation in other research that may influence the testing of the A3D study

Carrier of a pacemaker, valve prosthesis or other internal magnetic or electronic system, history of neurosurgery or aneurysm surgery, presence of metal fragments in the eyes, brain or marrow, claustrophobia

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

9 Participants
are divided into 2 treatment groups
Group A: 50 millions AdMSC doseExperimental treatment 3 interventions
Group B: 100 millions AdMSc doseExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

number of participants in each group with a clinically significant serious or non-serious AE related to treatment

The primary outcome is the number of participants in each group with a clinically significant serious or non-serious AE related to treatment. Each AE report should include a description of the event, an assessment of its severity, duration, severity, and causality with IV administration of AdMSC. The occurrence of an AE will be assessed by clinical (at selection visit, injection visit, 1 week, 1 month, 3 months, and 6 months), biological (at selection visit, injection visit, 1 week, 1 month, 3 months, and 6 months) and neuroimaging exams (at selection visit, 3 months, and 6 months).

Time frame
6 months

Secondary outcomes

1

determination of measures related to immunomodulatory activity (composite outcome)

Measures related to immunomodulatory activity: inflammatory (IL-1β, IL-6, TGF-β1, TNF-α, CRP, D-Dimers) and anti-inflammatory (IL-10) blood markers. Markers derived from brain MRI scan (Magnetic resonance sequence Spectroscopy MRS, in the posterior cingulate region, myo-inositol). Immunomonitoring with evaluation of activated T lymphocytes (CD3/CD25/CD69).

Time frame
6 months
2

determination of measures related to cerebral amyloid load (composite outcome)

Measures related to cerebral amyloid load: The global standardized relative Uptake Value ratio (SUVr) and by regions of interest (anterior cingulum, posterior cingulum, temporal, parietal, precuneus, frontal) assessed by amyloid PET scan (flutémétamol).

Time frame
6 months
3

determination of measures related to neurotrophic activity (composite outcome)

Cortical thickness assessed by brain MRI scan (T1 weighted sequence). Blood light chain neurofilaments. N-AcetylAspartate by MRS (posterior cingulum)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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