Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease

NCT07367815 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: RC31/19/05012022-502846-28-00
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease,; phase I/II,; safety,; mesenchymal stem cell,; adipose tissue

Outcome Measures

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).

  6 months

Secondary Outcomes (3)

• determination of measures related to immunomodulatory activity (composite outcome)

  6 months

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

  6 months

• determination of measures related to neurotrophic activity (composite outcome)

  6 months

Study Arms (2)

50 millions AdMSC dose

EXPERIMENTAL

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; Diagnostic Test: cerebral RMI; Diagnostic Test: PET scan

100 millions AdMSc dose

EXPERIMENTAL

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.

Drug: CellREADY® drug product IV dose of 100 millions; Diagnostic Test: cerebral RMI; Diagnostic Test: PET scan

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.

50 millions AdMSC dose

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.

100 millions AdMSc dose

cerebral RMI DIAGNOSTIC_TEST

cerebral RMI at V1, V5 and V6

100 millions AdMSc dose; 50 millions AdMSC dose

PET scan DIAGNOSTIC_TEST

amyloïde PET scan (flutémétamol) at V1 and V6

100 millions AdMSc dose; 50 millions AdMSC dose

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Julien DELRIEU, MD_PH

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien DELRIEU, MD-PH

CONTACT

05 61 77 70 58; delrieu.j@chu-toulouse.fr

Delphine Pennetier

CONTACT

pennetier.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01