Adipose-derived stem cells given by IV for Alzheimer’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

A3D is a phase I/II trial that examines the safety of allogeneic adipose tissue–derived stem cells (AdMSC) given IV to adults with mild to moderate Alzheimer’s disease using a dose-escalation design. The study uses 50 million cells initially, with the possibility of escalating to 100 million cells after a safety review at 6 months. Participants undergo imaging with cerebral MRI and PET, and receive standard clinical assessments to monitor safety and potential signals of benefit. The trial is led by University Hospital, Toulouse, with no listed collaborators, and enrolls adults aged 50–85 who meet biomarker and cognitive criteria for AD.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital of Toulouse
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Julien DELRIEU, MD_PH — University Hospital of Toulouse
• Study coordinator: Julien DELRIEU, MD-PH
• Email: delrieu.j@chu-toulouse.fr
• Phone: 05 61 77 70 58

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.