Health Trials

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

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

Treatments tested in this trial

  • CellREADY® drug product IV dose of 50 millions
  • CellREADY® drug product IV dose of 100 millions
  • cerebral RMI
  • PET scan

Treatment groups

9 Participants
are divided into 2 treatment groups

Locations

1
University Hospital of Toulouse Toulouse France

Sponsors and collaborators

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov