Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
NCT ID: NCT04466007
Last Updated: 2025-04-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
90 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-11
Study Completion Date
2024-12-05
Brief Summary
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Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
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Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
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Detailed Description
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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.
Main valuation variable: Proportion of Adverse Events related to treatment.
Conditions
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Limb Ischemia
Diabetic Foot
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Control arm
0.9% physiological saline
Group Type
PLACEBO_COMPARATOR
Placebos
Intervention Type
DRUG
0,9% physiological saline
Low dose treatment arm
Low dose allogeneic mesenchymal stem cells derived from adipose tissue
Group Type
EXPERIMENTAL
Low dose allogeneic mesenchymal stromal cells
Intervention Type
DRUG
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
High dose treatment arm
High dose allogeneic mesenchymal stem cells derived from adipose tissue
Group Type
EXPERIMENTAL
High dose allogeneic mesenchymal stromal cells
Intervention Type
DRUG
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
Interventions
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High dose allogeneic mesenchymal stromal cells
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
Intervention Type
DRUG
Low dose allogeneic mesenchymal stromal cells
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
Intervention Type
DRUG
Placebos
0,9% physiological saline
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
40 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Sponsor Role
collaborator
Hospital Universitario La Paz
OTHER
Sponsor Role
collaborator
Gregorio Marañón Hospital
OTHER
Sponsor Role
collaborator
Hospital Clínico Universitario de Valladolid
OTHER
Sponsor Role
collaborator
Hospital Universitario Virgen de la Arrixaca
OTHER
Sponsor Role
collaborator
University of Salamanca
OTHER
Sponsor Role
collaborator
Hospital General Universitario de Alicante
OTHER
Sponsor Role
collaborator
Hospital Universitario La Fe
OTHER
Sponsor Role
collaborator
Hospital Victoria Eugenia Cruz Roja Española
UNKNOWN
Sponsor Role
collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Hospital General de Alicante
Alicante, , Spain
Site Status
Hospital Gregorio Marañon
Madrid, , Spain
Site Status
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Site Status
La Paz University Hospital
Madrid, , Spain
Site Status
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, , Spain
Site Status
Clinica Universidad de Navarra
Pamplona, , Spain
Site Status
Hospital Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital Victoria Eugenia Cruz Roja Española
Seville, , Spain
Site Status
Hospital Universitario La Fe
Valencia, , Spain
Site Status
Hospital de Valladolid
Valladolid, , Spain
Site Status
Countries
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Spain
References
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BACKGROUND
Meloni M, Izzo V, Giurato L, Del Giudice C, Da Ros V, Cervelli V, Gandini R, Uccioli L. Recurrence of Critical Limb Ischemia After Endovascular Intervention in Patients with Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2018 Jun 1;7(6):171-176. doi: 10.1089/wound.2017.0778.
Reference Type
BACKGROUND
Neupane S, Edla S, Maidona E, Sweet MC, Szpunar S, Davis T, LaLonde TA, Mehta RH, Rosman HS, Yamasaki H. Long-term outcomes of patients with diabetes mellitus undergoing percutaneous intervention for popliteal and infrapopliteal peripheral arterial disease. Catheter Cardiovasc Interv. 2018 Jul;92(1):117-123. doi: 10.1002/ccd.27571. Epub 2018 Mar 14.
Reference Type
BACKGROUND
Spillerova K, Settembre N, Biancari F, Alback A, Venermo M. Angiosome Targeted PTA is More Important in Endovascular Revascularisation than in Surgical Revascularisation: Analysis of 545 Patients with Ischaemic Tissue Lesions. Eur J Vasc Endovasc Surg. 2017 Apr;53(4):567-575. doi: 10.1016/j.ejvs.2017.01.008. Epub 2017 Feb 16.
Reference Type
BACKGROUND
Dubsky M, Husakova J, Sojakova D, Fejfarova V, Jude EB. Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence? Mol Diagn Ther. 2023 Nov;27(6):673-683. doi: 10.1007/s40291-023-00667-w. Epub 2023 Sep 22.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOMA (No More Amputations)
Identifier Type: -
Identifier Source: org_study_id
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