Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia

October 2, 2023 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Multicenter, Randomized, Dose-search, Parallel, Double-blind, and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Intramuscular Administration of Allogeneic Adipose Tissue Adult Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia Without Possibility of Revascularization

Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Disease or disorder under study: Critical ischemia of the lower limbs in diabetic patients without the possibility of revascularization.

Main valuation variable: Proportion of Adverse Events related to treatment.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

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 Locations

  • Spain
      • Alicante, Spain
        • Hospital General de Alicante
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • La Paz University Hospital
      • Murcia, Spain
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Pamplona, Spain
        • Clinica Universidad de Navarra
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Sevilla, Spain
        • Hospital Victoria Eugenia Cruz Roja Española
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valladolid, Spain
        • Hospital de Valladolid

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

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients must meet ALL of the following criteria to be included in the study:

  • Patients of both sexes.
  • Age between 40 and 90 years.
  • Severe grade vascular arteriosclerosis (category RB 4 and 5 mono or bilateral).
  • Impossibility of surgical or endovascular revascularization or failure in revascularization surgery performed, at least 30 days before inclusion in the study, defining failure as direct non-arrival of vessels to the plantar arch.

  • Normal biochemical parameters defined by:

    • Leukocytes> 3000 / mm3
    • Neutrophils> 1500 / mm3
    • Platelets> 100,000 / mm3
    • AST / ALT <2.5x upper limit of normal
  • In patients with an ischemic ulcer, it must be stable for at least 1 week.
  • Patients under conventional medical treatment for CLI.
  • Women of childbearing age must obtain a negative result in a urine pregnancy test performed at the time of inclusion in the study and commit to using an effective contraceptive method during their participation in the study.
  • Patients who have not participated in any other clinical trial during the 3 months prior to the inclusion visit.
  • Patients who sign the informed consent.

Exclusion Criteria:

Patients who present SOME of the following criteria may not be selected to participate in this study:

  • CLI with tissue loss in the target member (category 6 of RB).
  • Previous major amputation in the target member.
  • Uncontrolled hypertension (defined as PAS> 180 or PAD> 110 in at least 2 determinations during the selection period).
  • Patients with severe heart failure or ejection fraction less than 30%.
  • Patients with a previous diagnosis of ventricular arrhythmias or unstable angina.
  • Patients with septicemia.
  • Patients diagnosed with deep vein thrombosis in the 3 months prior to their inclusion in the study.
  • Concomitant therapy that includes hyperbaric oxygen, angiogenic agents or Cox II inhibitors.
  • Contraindication to perfusion NMR.
  • Proliferative retinopathy without treatment.
  • Diabetic nephropathy in hemodialysis.
  • Patients previously treated with cell therapy, gene therapy or growth factors in the last year.
  • Concomitant disease that limits life expectancy to 1 year or that does not ensure the follow-up period.
  • Patients who have suffered a stroke or myocardial infarction in the 3 months prior to the inclusion visit.
  • Severe anemia (hemoglobin <7.9g / dl) in the inclusion analysis.
  • Patients with a previous diagnosis of chronic alcoholism.
  • Any clinically significant anomaly detected in the Selection Period and which, in the opinion of the investigator, constitutes an impediment to the correct participation of the patient in the study or the fulfillment of the procedures established therein.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control arm
0.9% physiological saline
Drug: Placebos
0,9% physiological saline
Experimental: Low dose treatment arm
Low dose allogeneic mesenchymal stem cells derived from adipose tissue
Drug: Low dose allogeneic mesenchymal stromal cells
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
Experimental: High dose treatment arm
High dose allogeneic mesenchymal stem cells derived from adipose tissue
Drug: High dose allogeneic mesenchymal stromal cells
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rate after treatment administration
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of vascularization though RMN
Time Frame: 1 year
1 year
Rutherford-Becker scale
Time Frame: 1 year
1 year
Wifi scale
Time Frame: 1 year
1 year
Ankle arm index
Time Frame: 1 year
1 year
Temperature
Time Frame: 1 year
(ºC)
1 year
Twin perimeter
Time Frame: 1 year
(cm)
1 year
Neuropathic symptoms (altered sensitivity)
Time Frame: 1 year
1 year
% amputations
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
SF-12 questionnaire
Time Frame: 1 year
1 year
VascuQol-6 questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Clinica Universidad de Navarra, Universidad de Navarra
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario La Fe
University of Salamanca
Hospital Universitario La Paz
Hospital General Universitario de Alicante
Hospital Clínico Universitario de Valladolid
Gregorio Marañón Hospital
Hospital Victoria Eugenia Cruz Roja Española

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 11, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOMA (No More Amputations)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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