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Completed

NCT Number: NCT05631444

Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia

Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.

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.

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Ischemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fundación Oftalmológica de Santander (FOSCAL)

Bucaramanga, Colombia

About this study

Comparison of the therapeutic potential of BM-MNC vs. allogeneic Wharton jelly-derived mesenchymal stem cells (allo-WJ-MSCs) in diabetic patients with CLTI.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female, 40 years of age or over (until 85 years old)
  • 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

  • Participants that do not sign the informed consent.
  • 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.

Treatment and study plan

Cell-based therapy

Biological

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.

Primary outcomes

  1. Safety profile: (adverse events (AEs) and serious AEs)

    Time frame: 12 months

    AEs: (i) local toxicity, including signs of local inflammation (swelling, warmth, impairment of function), worsening of ulcer, new ulcer, or hematomas after auto-BM-MNC or allo-WJ-MSCs administration.

    (ii) systemic toxicity as fever, allergies. (iii) maximum grade toxicity for tissue.

  2. Safety profile

    Time frame: 12 months

    Serious AEs: hospitalization, malignancy, amputation, persistent or significant disability, or death.

  3. Efficacy profile: Rutherford's classification

    Time frame: 12 months

    0 to 6

  4. TcPO2

    Time frame: 12 months

    mmHg

  5. Efficacy profile: Visual Analogue Scale pain

    Time frame: 12 months

    0 to10

  6. Efficacy profile: Pain-free walking distance

    Time frame: 12 months

    meters

  7. Efficacy profile: Wound closure

    Time frame: 12 months

    cm2

  8. Efficacy profile: Revascularization

    Time frame: 12 months

    Percentage

  9. Efficacy profile: Limb survival proportion

    Time frame: 12 months

    Percentage

  10. Efficacy profile: Quality of life

    Time frame: 12 months

    EQ-5D questionnaire

Sponsors and collaborators

Lead sponsor

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Other

Registry information

Official study title

Comparison of the Therapeutic Potential of Autologous Bone Marrow Mononuclear Cells Versus Allogenic Wharton Jelly-derived Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb-threatening Ischemia

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Nov 30, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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