Critical Limb IschemiaPhase 1AlloDREAMNCT06795620
Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.
A Phase 1 study testing Adipose tissue derived mesenchymal Stroma/stem Cells transplantation in people with Critical Limb Ischemia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Adipose tissue derived mesenchymal Stroma/stem Cells transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2025to Jan 2028
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old,
- Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,
- Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,
- Patient with a life expectancy greater than 6 months,
- Patients who signed the informed consent,
- Women of childbearing age with effective contraception (oral contraception, IUD, dermal implant) and with negative pregnancy test,
- Patient affiliated to a social security system.
Who cannot join
- Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,
- Another clinical trial participation (except observational studies),
- Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,
- Patient allergic to local anesthetics
- Immunosuppressive therapy
- Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
- Patient under the protection of justice or under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Toulouse
Toulouse, France
François Xavier LAPEBIE, MD, 0561322638 ext. +33, lapebie.fx@chu-toulouse.fr
François-Xavier LAPEBIE, MD
About this study
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.
Read the detailed description
Lower limbs arteries are a frequent localization of atheroma in elderly people (15-20% after 70 years). The most severe stage of the disease, critical limb ischemia (CLI), defined clinically by the presence of rest pain or ischemic ulcer with an ankle pressure <50 mmHg or a toe pressure <30 mmHg or a TcPO2 <30 mmHg, has a dramatic prognosis at 12 months, with 30% of the patients alive with an amputation, 20% mortality and only 20% of patients with a resolved disease, independently from the treatment. The only validated treatment for this disease is revascularization by endovascular procedures or open surgery. Patients with no option or poor option (high risk) for revascularization have the worst prognosis. Regenerative medicine has been studied in this field, by the injection of bone marrow derived stem cells in the ischemic limb to improve neo-angiogenesis. Despite the encouraging first results, few studies have shown a clinical interest of this kind of approach. The products tested were heterogeneous compounds derived from the bone marrow.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues.
Scientists already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with CLI and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing.
In order to optimize the quality of the AdMSC, to avoid the abdominal sample under anesthesia in the already suffering patients and to have the cellular product available quickly, without waiting the 15 days of culture, researchers envisage the use of AdMSC of allogeneic origin taken from healthy donors and cryopreserved after culture. Indeed, the results of phase 1 of ACellDREAM showed that almost half of the patients suffering from IC had to be amputated during the 15 days of culture. Preliminary experiments show that the phenotypic characteristics, in vitro properties and in vivo biodistribution of these cells after freezing are unchanged.
Researchers are planning a single phase, phase I study to evaluate the tolerability of intramuscular injection of allogeneic AUC in patients with critical non-revascularizable ischemia, or with persistent ischemia despite revascularization.
The aim of this phase I is to evaluate safety of allogeneic AdMSC transplantation in patients with critical limb ischemia with poor options or no option for revascularization. Ten patients will be included and have AdMSC injection in their ischemic leg. Patients will be follow-up during six months to evaluate ulcer evolution, wound healing, pain, blood flow and immune response in blood samples.
- Conditions
- Critical Limb Ischemia
- Being tested
- Adipose tissue derived mesenchymal Stroma/stem Cells transplantation
- Keywords
- Adipose tissue, allogeneic AdMSC, cell therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue derived mesenchymal Stroma/stem Cells transplantationDrug
Allogeneic adipose tissue-derived stromal cells (AdMSC) (CellReady ® drug) will be administered intramuscularly into the ischemic limb (dose of 90x10^6 AdMSC) of patients. They will be followed at 1 day, 7 days, 30 days, 90 days, and 180 days after the injection.
| Study group | Role | What they receive |
|---|---|---|
| CellReady | Experimental | All the patients will be included and will have AdMSC injections (CellReady®) in their ischemic led. They will be follow-up during 6 months. Receives: Drug: Adipose tissue derived mesenchymal Stroma/stem Cells transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the tolerance
local and systemic tolerance during 6 months by the collection and analysis of adverse events (serious or non-serious) throughout the duration of the study
Measured: 6 months
Secondary outcomes (12)
Evaluation of the efficacy of the treatment on critical limb ischemia.
Proportion of patients without criteria of CLI
Measured: Day 30, Day 90, and Day 180
Evaluation of the evolution of ischemia objective parameters.
Pressures, laser-Doppler and TcPO2
Measured: Day 0, Day 30, Day 90, and Day 180
Evaluation of the healing.
Number of complete scarring
Measured: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients who required a major amputation.
Measured: Day 180
Evaluation of the pain Evolution
VAS (visual analogue scale), consumption of morphine or non-morphine analgesics
Measured: Day 0, Day 7, Day 30, Day 90, and Day 180
Evaluation of the neovascularization on the treated leg.
Determination of the number of neo-vessels formed by angiography, angio Magnetic resonance imaging (MRI) or angio-scanner.
Measured: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients included who had all the injections.
Measured: Day 0
Evaluation of the evolution of the quality of life
Claudication Scale (CLAU-S®)
Measured: Day 0, Day 30, Day 90, and Day 180
Evaluation of the security.
Description of all adverse reaction during the trial
Measured: Day 0, Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the immunomodulatory activity of the injected cells.
- Immuno-monitoring by evaluation of the different circulating immune populations (Th1, Th2, Th17, Treg ...) associated with functional tests in vitro and immunological assays of pro and anti-inflammatory cytokines (IL-1, IL-2, IL-4, IL-6, IL-10, IL-12, TNFα, IFNγ).
Measured: Evaluated at Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the patient's immune response against Adipose-derived mesenchymal stem cells (AdMSCs)
Dosage of anti HLA (human leukocyte antigen) donor antobodies.
Measured: Day 30
Evaluation of the evolution of the quality of life.
EuroQol (EQ-5D-5L)
Measured: Day 0, Day 30, Day 90, and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Xavier LAPEBIE, Dr, Principal investigator, Service de Médecine Vasculaire, Hôpital Rangueil, CHU de Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795620
- Sponsor's protocol ID
- RC31/21/0168
- Other IDs
- 2023-509312-29-00, 2023
- Acronym
- AlloDREAM
- Status last verified
- Jan 2025
- First submitted
- 16 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.
- ClinicalTrials.gov ID
- NCT06795620
- Acronym / sponsor ID
- AlloDREAM / RC31/21/0168
- Conditions
- Critical Limb Ischemia
- Keywords
- Adipose tissue, allogeneic AdMSC, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Jan 2025 (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.
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.
Detailed description
Lower limbs arteries are a frequent localization of atheroma in elderly people (15-20% after 70 years). The most severe stage of the disease, critical limb ischemia (CLI), defined clinically by the presence of rest pain or ischemic ulcer with an ankle pressure <50 mmHg or a toe pressure <30 mmHg or a TcPO2 <30 mmHg, has a dramatic prognosis at 12 months, with 30% of the patients alive with an amputation, 20% mortality and only 20% of patients with a resolved disease, independently from the treatment. The only validated treatment for this disease is revascularization by endovascular procedures or open surgery. Patients with no option or poor option (high risk) for revascularization have the worst prognosis. Regenerative medicine has been studied in this field, by the injection of bone marrow derived stem cells in the ischemic limb to improve neo-angiogenesis. Despite the encouraging first results, few studies have shown a clinical interest of this kind of approach. The products tested were heterogeneous compounds derived from the bone marrow.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues.
Scientists already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with CLI and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing.
In order to optimize the quality of the AdMSC, to avoid the abdominal sample under anesthesia in the already suffering patients and to have the cellular product available quickly, without waiting the 15 days of culture, researchers envisage the use of AdMSC of allogeneic origin taken from healthy donors and cryopreserved after culture. Indeed, the results of phase 1 of ACellDREAM showed that almost half of the patients suffering from IC had to be amputated during the 15 days of culture. Preliminary experiments show that the phenotypic characteristics, in vitro properties and in vivo biodistribution of these cells after freezing are unchanged.
Researchers are planning a single phase, phase I study to evaluate the tolerability of intramuscular injection of allogeneic AUC in patients with critical non-revascularizable ischemia, or with persistent ischemia despite revascularization.
The aim of this phase I is to evaluate safety of allogeneic AdMSC transplantation in patients with critical limb ischemia with poor options or no option for revascularization. Ten patients will be included and have AdMSC injection in their ischemic leg. Patients will be follow-up during six months to evaluate ulcer evolution, wound healing, pain, blood flow and immune response in blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CellReady | Experimental | Drug: Adipose tissue derived mesenchymal Stroma/stem Cells transplantationAll the patients will be included and will have AdMSC injections (CellReady®) in their ischemic led. They will be follow-up during 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years old,
- Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,
- Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,
- Patient with a life expectancy greater than 6 months,
- Patients who signed the informed consent,
Key exclusion criteria (7 listed)
- Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,
- Another clinical trial participation (except observational studies),
- Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,
- Patient allergic to local anesthetics
- Immunosuppressive therapy
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 |
|---|---|---|
| Adipose tissue derived mesenchymal Stroma/stem Cells transplantationAllogeneic adipose tissue-derived stromal cells (AdMSC) (CellReady ® drug) will be administered intramuscularly into the ischemic limb (dose of 90x10^6 AdMSC) of patients. They will be followed at 1 day, 7 days, 30 days, 90 days, and 180 days after the injection. | Drug | CellReady |
Primary outcome
Evaluation of the tolerance
Time frame: 6 months
local and systemic tolerance during 6 months by the collection and analysis of adverse events (serious or non-serious) throughout the duration of the study
12 secondary outcomes
Evaluation of the efficacy of the treatment on critical limb ischemia.
Time frame: Day 30, Day 90, and Day 180
Evaluation of the evolution of ischemia objective parameters.
Time frame: Day 0, Day 30, Day 90, and Day 180
Evaluation of the healing.
Time frame: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients who required a major amputation.
Time frame: Day 180
Evaluation of the pain Evolution
Time frame: Day 0, Day 7, Day 30, Day 90, and Day 180
Evaluation of the neovascularization on the treated leg.
Time frame: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients included who had all the injections.
Time frame: Day 0
Evaluation of the evolution of the quality of life
Time frame: Day 0, Day 30, Day 90, and Day 180
Evaluation of the security.
Time frame: Day 0, Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the immunomodulatory activity of the injected cells.
Time frame: Evaluated at Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the patient's immune response against Adipose-derived mesenchymal stem cells (AdMSCs)
Time frame: Day 30
Evaluation of the evolution of the quality of life.
Time frame: Day 0, Day 30, Day 90, and Day 180
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
François-Xavier LAPEBIE, Dr principal investigator
Service de Médecine Vasculaire, Hôpital Rangueil, CHU de 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 study testing Adipose tissue derived mesenchymal Stroma/stem Cells transplantation in people with Critical Limb Ischemia, 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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 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.
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 François-Xavier LAPEBIE, Dr (+33 5 61 32 24 38, lapebie.fx@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the tolerance (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 28 Jan 2025.