Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease (A3D)

January 19, 2026 updated by: University Hospital, Toulouse

Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I/II 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bone narrow derived-stem cells (MSC) or adipose tissue-derived stem cells (AdMSC) are widely used in clinical research. The allogeneic approach is currently being considered in indications such as Crohn's disease and graft-versus-host disease. The potential effects of MSCs would be associated with paracrine effects via the secretion of neurotrophic cytokines capable of stimulating endogenous neurogenesis, anti-inflammatory, and immuno-modulatory factors. The recent CRATUS study consisting of IV administration of allogeneic MSCs in frail elderly participants showed a positive effect on functional performance, cognitive performance and inflammation measures. A3D is a phase I/II clinical trial whose primary objective is to evaluate the safety of allogeneic AdMSC IV administration in mild to moderate AD using a dose escalation protocol. Initially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients injected by 50x106 AdMSC does not show clinically significant adverse events (AE) after 6 months of evaluation, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if the safety analysis of the first 3 patients shows a clinically significant AE related to the treatment, 3 new patients will be infused 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.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient between 50 and 85 years old
  • AD diagnosis according to NIA-AA 2011 criteria at a mild to moderate stage :

MMSE score between 14 and 26 (include) positive AD amyloid biomarker

  • CDR (clinical dementia rating) score ≥ 1
  • Patient with no absolute contraindications for PET or MRI scans
  • Consent signed by the patient and study partner
  • presence of primary caregiver
  • Patient with social security coverage

Exclusion Criteria:

  • 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
  • PET scan performed in the previous year (research context)
  • History of cancer diagnosed within the last 5 years
  • Presence of > 4 brain microbleeds, a single area of superficial siderosis, or evidence of previous macrohaemorrhage assessed by brain MRI scan
  • Regular use of corticosteroids or other steroidal anti-inflammatory drugs (e. g. prednisone)
  • Presence of an autoimmune disease (e. g. rheumatoid arthritis, systemic lupus erythematosus) with the exception of psoriasis
  • Pregnant or breastfeeding woman
  • Adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision For patients who will participate in the optional adipose puncture (only carried out in the Toulouse center): Antithrombotic treatment and xylocaine allergy are prohibited.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: CellREADY® drug product IV dose of 50 millions

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.

Diagnostic test: cerebral RMI
cerebral RMI at V1, V5 and V6
Diagnostic test: PET scan
amyloïde PET scan (flutémétamol) at V1 and V6
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.
Diagnostic test: cerebral RMI
cerebral RMI at V1, V5 and V6
Diagnostic test: PET scan
amyloïde PET scan (flutémétamol) at V1 and V6
Drug: CellREADY® drug product IV dose of 100 millions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants in each group with a clinically significant serious or non-serious AE related to treatment
Time Frame: 6 months
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of measures related to immunomodulatory activity (composite outcome)
Time Frame: 6 months
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).
6 months
determination of measures related to cerebral amyloid load (composite outcome)
Time Frame: 6 months
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).
6 months
determination of measures related to neurotrophic activity (composite outcome)
Time Frame: 6 months
Cortical thickness assessed by brain MRI scan (T1 weighted sequence). Blood light chain neurofilaments. N-AcetylAspartate by MRS (posterior cingulum)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Julien DELRIEU, MD_PH, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/19/0501
  • 2022-502846-28-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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