Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
NCT ID: NCT05631444
Last Updated: 2022-11-30
Study Results
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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COMPLETED
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2019-01-01
2022-10-28
Brief Summary
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There is an urgent need to develop an effective therapeutic strategy to treat this disease. In this context, autologous bone marrow mononuclear cells (BM-MNC) and allogeneic mesenchymal stem cells derived from different sources have emerged as promising therapeutic approaches for this condition.
Detailed Description
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Twenty-four type 2 diabetic patients in the most severe stages of the CLTI (category 4 or 5 in Rutherford's classification and transcutaneous oxygen pressure (TcPO2) below 30 mm Hg were enrolled and randomized to receive 15 injections of (i) BM-MNC (7.197x106 ± 2.984 x106 cells/mL each with 2% of autologous serum) (n=7), (ii) allo-WJ-MSCs (1.333 x106 cells/mL each with 5% of human serum albumin serum) (n=7) or (iii) placebo solution (1 mL saline solution with 2% of autologous serum) (n=10), which were administered into the periadventitial arteries.
The follow-up visits were at months 1, 3, 6, and 12, to evaluate the following parameters:
(i) Rutherford classification (0 to 6) (ii) TcPO2 (mmHg) (iii) Wound closure (area cm2) (iv) pain (visual analogue scale (0-10) (v) pain-free walking distance (m) (vi) revascularization and limb-survival proportion during follow-up (vii) the quality of life (EQ-5D questionnaire).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo group
Placebo group (n=10), which consisted of 15 injections of 1 mL of vehicle (1 mL saline solution with 2% of autologous serum) on periadventitial arteries in one dose at day 0.
Cell-based therapy
One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Auto-BM-MNC
Auto-BM-MNC (n=7) were obtained from diabetic patients. Fifteen injections of 7.197x106 ± 2.984x106 cells/mL each with 2% of autologous serum were periadventitial arteries administrated in one dose at day 0.
Cell-based therapy
One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Allo-WJ-MSCs
Allo-WJ-MSCs (n=7) were obtained from culturing the WJ from healthy cordon umbilical donors unrelated to the patient. Fifteen injections of 1.333x106 cells/mL each with 5% of human serum albumin serum were periadventitial arteries administrated in one dose at day 0.
Cell-based therapy
One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Interventions
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Cell-based therapy
One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Eligibility Criteria
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Inclusion Criteria
* TcPO2 ≤ 30 mmHg.
* Diagnosis of diabetes.
* Patients with signs of critical ischemia such as (i) ulcer that does not heal, (ii) necrosis or loss of tissue, (iii) pain at rest, and (iv) intermittent claudication.
* Basal Rutherford classification stage 3 to 5.
* Non-revascularizable patients due to comorbidities and/or anatomy.
* Patients that despite revascularization (vascular surgery), have adequate distal beds to perfuse the limb.
* Ankle/brachial index less than 0.4.
* Stenosis or occlusion of the infrapatellar arteries.
Exclusion Criteria
* Presence of osteomyelitis.
* Hemodynamic instability (MAP\<65 mmHg or vasopressor requirement).
* Any acute systemic infectious disease process.
* Severe sepsis.
* Uncontrolled coagulopathy.
* Condition of cancer.
* Use of immunosuppressive or cytotoxic drugs
* Alterations of the bone marrow that do not allow the adequate extraction of the components to be used as: acute leukemia, chronic leukemia, marrow aplasia, myelodysplastic syndrome, and myelophthisis.
* Contraindication of sedation for bone marrow aspirate.
* Patients who have suffered in a period \< six months of myocardial infarction, disease cerebrovascular or coronary intervention.
* Patients with liver failure indicated by serum transaminases (aspartate aminotransferase and alanine aminotransferase), with values twice the normal limit.
* Any acute or chronic contagious disease including hepatitis B, hepatitis C, and HIV.
* Any other comorbidity that the treating vascular surgeon considers as a contraindication to cell treatments.
40 Years
85 Years
ALL
No
Sponsors
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Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
OTHER
Responsible Party
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Martha Ligia Arango Rodríguez
Director Technical and Scientific Centro de Terapias Avanzadas Fundación Ofalmológica de Santander (FOSCAL)
Principal Investigators
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Martha L Arango, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Locations
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Fundación Oftalmológica de Santander (FOSCAL)
Bucaramanga, , Colombia
Countries
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References
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Arango-Rodriguez ML, Mateus LC, Sossa CL, Becerra-Bayona SM, Solarte-David VA, Ochoa Vera ME, Viviescas LTG, Berrio AMV, Serrano SE, Vargas O, Isla AC, Benitez A, Rangel G. A novel therapeutic management for diabetes patients with chronic limb-threatening ischemia: comparison of autologous bone marrow mononuclear cells versus allogenic Wharton jelly-derived mesenchymal stem cells. Stem Cell Res Ther. 2023 Aug 25;14(1):221. doi: 10.1186/s13287-023-03427-z.
Other Identifiers
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CLTI 01
Identifier Type: -
Identifier Source: org_study_id