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

NCT04466007 | Completed Phase 2

• 1 other identifier: NOMA (No More Amputations)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Limb Ischemia; Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Complication rate after treatment administration

  1 year

Secondary Outcomes (8)

• Evaluation of vascularization though RMN

  1 year

• Rutherford-Becker scale

  1 year

• Wifi scale

  1 year

• Ankle arm index

  1 year

• Temperature

  1 year

Other Outcomes (2)

• SF-12 questionnaire

  1 year

• VascuQol-6 questionnaire

  1 year

Study Arms (3)

Control arm

PLACEBO COMPARATOR

0.9% physiological saline

Drug: Placebos

Low dose treatment arm

EXPERIMENTAL

Low dose allogeneic mesenchymal stem cells derived from adipose tissue

Drug: Low dose allogeneic mesenchymal stromal cells

High dose treatment arm

EXPERIMENTAL

High dose allogeneic mesenchymal stem cells derived from adipose tissue

Drug: High dose allogeneic mesenchymal stromal cells

Interventions

High dose allogeneic mesenchymal stromal cells DRUG

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

High dose treatment arm

Low dose allogeneic mesenchymal stromal cells DRUG

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

Low dose treatment arm

Placebos DRUG

0,9% physiological saline

Control arm

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Patients who sign the informed consent.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Hospital Universitario La Paz: collaborator
• Gregorio Marañón Hospital: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• University of Salamanca: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Universitario La Fe: collaborator
• Hospital Victoria Eugenia Cruz Roja Española: collaborator

Study Sites (10)

Hospital General de Alicante

Alicante, Spain

Location

Hospital Gregorio Marañon

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

La Paz University Hospital

Madrid, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Victoria Eugenia Cruz Roja Española

Seville, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital de Valladolid

Valladolid, Spain

Location

Related Publications (51)

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• Soria-Juan B, Garcia-Arranz M, Llanos Jimenez L, Aparicio C, Gonzalez A, Mahillo Fernandez I, Riera Del Moral L, Grochowicz L, Andreu EJ, Marin P, Castellanos G, Moraleda JM, Garcia-Hernandez AM, Lozano FS, Sanchez-Guijo F, Villaron EM, Parra ML, Yanez RM, de la Cuesta Diaz A, Tejedo JR, Bedoya FJ, Martin F, Miralles M, Del Rio Sola L, Fernandez-Santos ME, Ligero JM, Morant F, Hernandez-Blasco L, Andreu E, Hmadcha A, Garcia-Olmo D, Soria B. Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial). Trials. 2021 Sep 6;22(1):595. doi: 10.1186/s13063-021-05430-2.

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MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: January 11, 2021
• Primary Completion: May 27, 2024
• Study Completion: December 5, 2024
• Last Updated: April 27, 2025

Record last verified: 2024-10

Locations

ES (10)