NCT07367815 Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease
| NCT ID | NCT07367815 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Toulouse |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2026-05-07 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Julien DELRIEU, MD_PH
PRINCIPAL INVESTIGATOR
University Hospital of Toulouse
Frequently Asked Questions
Who can join the NCT07367815 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07367815 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07367815 currently recruiting?
Yes, NCT07367815 is actively recruiting participants. Contact the research team at delrieu.j@chu-toulouse.fr for enrollment information.
Where is the NCT07367815 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT07367815 clinical trial?
NCT07367815 is sponsored by University Hospital, Toulouse. The principal investigator is Julien DELRIEU, MD_PH at University Hospital of Toulouse. The trial plans to enroll 9 participants.
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