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

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ClinicalTrials.gov Identifier: NCT04466007
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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

Condition or disease Intervention/treatment Phase
Limb Ischemia Diabetic Foot Drug: High dose allogeneic mesenchymal stromal cells Drug: Low dose allogeneic mesenchymal stromal cells Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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 tidssue administeres 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




Primary Outcome Measures :
  1. Complication rate after treatment administration [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluation of vascularization though RMN [ Time Frame: 1 year ]
  2. Rutherford-Becker scale [ Time Frame: 1 year ]
  3. Wifi scale [ Time Frame: 1 year ]
  4. Ankle arm index [ Time Frame: 1 year ]
  5. Temperature [ Time Frame: 1 year ]
    (ºC)

  6. Twin perimeter [ Time Frame: 1 year ]
    (cm)

  7. Neuropathic symptoms (altered sensitivity) [ Time Frame: 1 year ]
  8. % amputations [ Time Frame: 1 year ]

Other Outcome Measures:
  1. SF-12 questionnaire [ Time Frame: 1 year ]
  2. VascuQol-6 questionnaire [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Type 2 diabetes established with more than 1 year since diagnosis.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466007


Contacts
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Contact: Mireia Arcas +34915504800 ext 3214 mireia.arcas@fjd.es

Locations
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Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Spain
Contact: Mireia Arcas         
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Publications:
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.

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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT04466007    
Other Study ID Numbers: NOMA (No More Amputations)
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Ischemia
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies