Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/stem Cells (AdMSC) Transplantation in Patients with Critical Limb Ischemia. (AlloDREAM)

January 23, 2025 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse
        • Contact:
        • Contact:
          • François-Xavier LAPEBIE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CellReady
All the patients will be included and will have AdMSC injections (CellReady®) in their ischemic led. They will be follow-up during 6 months.
Drug: Adipose tissue derived mesenchymal Stroma/stem Cells transplantation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of the treatment on critical limb ischemia.
Time Frame: Day 30, Day 90, and Day 180
Proportion of patients without criteria of CLI
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
Pressures, laser-Doppler and TcPO2
Day 0, Day 30, Day 90, and Day 180
Evaluation of the healing.
Time Frame: Day 30, Day 90, and Day 180
Number of complete scarring
Day 30, Day 90, and Day 180
Evaluation of the proportion of patients who required a major amputation.
Time Frame: Day 180
Day 180
Evaluation of the pain Evolution
Time Frame: Day 0, Day 7, Day 30, Day 90, and Day 180
VAS (visual analogue scale), consumption of morphine or non-morphine analgesics
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
Determination of the number of neo-vessels formed by angiography, angio Magnetic resonance imaging (MRI) or angio-scanner.
Day 30, Day 90, and Day 180
Evaluation of the proportion of patients included who had all the injections.
Time Frame: Day 0
Day 0
Evaluation of the evolution of the quality of life
Time Frame: Day 0, Day 30, Day 90, and Day 180
Claudication Scale (CLAU-S®)
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
Description of all adverse reaction during the trial
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
- 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).
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
Dosage of anti HLA (human leukocyte antigen) donor antobodies.
Day 30
Evaluation of the evolution of the quality of life.
Time Frame: Day 0, Day 30, Day 90, and Day 180
EuroQol (EQ-5D-5L)
Day 0, Day 30, Day 90, and Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: François-Xavier LAPEBIE, Dr, Service de Médecine Vasculaire, Hôpital Rangueil, CHU de Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/21/0168
  • 2023-509312-29-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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