Alzheimer DiseasePhase 1/2A3DNCT07367815
Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease
A Phase 1/2 study testing CellREADY® drug product IV dose of 50 millions, CellREADY® drug product IV dose of 100 millions and cerebral RMI in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CellREADY® drug product IV dose of 50 millions, CellREADY® drug product IV dose of 100 millions and cerebral RMI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2026to 1 May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Delphine Pennetier contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Toulouse
Toulouse
Julien DELRIEU, PU-PH
Julien DELRIEU, PU-PH
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- CellREADY® drug product IV dose of 50 millions, CellREADY® drug product IV dose of 100 millions, cerebral RMI, PET scan
- Keywords
- Alzheimer disease,, phase I/II,, safety,, mesenchymal stem cell,, adipose tissue
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellREADY® drug product IV dose of 50 millionsDrug
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.
CellREADY® drug product IV dose of 100 millionsDrug
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.
cerebral RMIDiagnostic test
cerebral RMI at V1, V5 and V6
PET scanDiagnostic test
amyloïde PET scan (flutémétamol) at V1 and V6
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: CellREADY® drug product IV dose of 100 millions; Diagnostic Test: cerebral RMI; Diagnostic Test: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (3)
determination of measures related to immunomodulatory activity (composite outcome)
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).
Measured: 6 months
determination of measures related to cerebral amyloid load (composite outcome)
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).
Measured: 6 months
determination of measures related to neurotrophic activity (composite outcome)
Cortical thickness assessed by brain MRI scan (T1 weighted sequence). Blood light chain neurofilaments. N-AcetylAspartate by MRS (posterior cingulum)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start7 May 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien DELRIEU, MD_PH, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367815
- Sponsor's protocol ID
- RC31/19/0501
- Other IDs
- 2022-502846-28-00
- Acronym
- A3D
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I/II Trial
- ClinicalTrials.gov ID
- NCT07367815
- Acronym / sponsor ID
- A3D / RC31/19/0501
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease,, phase I/II,, safety,, mesenchymal stem cell,, adipose tissue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 millions AdMSC dose | Experimental | Drug: CellREADY® drug product IV dose of 50 millions, Diagnostic Test: cerebral RMI, Diagnostic Test: PET scanAllogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50x106 or 100x106 AdMSC (from 3 to 6 patients, "50x106 AdMSC " group, group 1) |
| 100 millions AdMSc dose | Experimental | Drug: CellREADY® drug product IV dose of 100 millions, Diagnostic Test: cerebral RMI, Diagnostic Test: PET scanAllogeneic 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellREADY® drug product IV dose of 50 millionsAllogeneic 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. | Drug | 50 millions AdMSC dose |
| CellREADY® drug product IV dose of 100 millionsAllogeneic 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. | Drug | 100 millions AdMSc dose |
| cerebral RMIcerebral RMI at V1, V5 and V6 | Diagnostic test | 100 millions AdMSc dose, 50 millions AdMSC dose |
| PET scanamyloïde PET scan (flutémétamol) at V1 and V6 | Diagnostic test | 100 millions AdMSc dose, 50 millions AdMSC dose |
Primary outcome
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).
3 secondary outcomes
determination of measures related to immunomodulatory activity (composite outcome)
Time frame: 6 months
determination of measures related to cerebral amyloid load (composite outcome)
Time frame: 6 months
determination of measures related to neurotrophic activity (composite outcome)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Pennetier contact
Julien DELRIEU, MD_PH principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CellREADY® drug product IV dose of 50 millions, CellREADY® drug product IV dose of 100 millions and cerebral RMI in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien DELRIEU, MD-PH (05 61 77 70 58 ext. +33, delrieu.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants in each group with a clinically significant serious or non-serious AE related to treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.