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NCT Number: NCT01818310

Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

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Key information

Conditions

Critical Lower Limb Ischemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Ischemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Type-2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Ostrava

Ostrava, 708 52, Czechia

About this study

Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes mellitus
  • diagnosis of critical limb ischemia
  • non-healing defect on the study limb
  • ABI value < 50 mmHg or ABI< 0.4
  • TBI value < 40 mmHg or TBI < 0.4
  • TcPO2 < 20 mmHg in supine position
  • no other suitable surgical or re-vascularization procedure
  • age > 18 years
  • signed Informed Consent

Exclusion criteria

  • non-signing of the Informed Consent
  • anticipated life expectancy < 6 months
  • history of bone-marrow disease
  • renal failure or dialysis dependency
  • known malignant disease
  • health risks excluding the possibility of general anaesthesia or sedation
  • life-threatening ischaemic heart disease
  • vast necrosis of the index limb
  • active infectious disease, or ATB treatment
  • treatment with immunosupressives
  • pregnancy, breastfeeding

Treatment and study plan

Group A: Intramuscular

Biological

Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml.

The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.

Group B: Intraarterial

Biological

Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.

Group C: Intravenous

Biological

Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.

Group D: Surgical endovascular treatment with maximum medicamentous treatment

Procedure

Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment

Primary outcomes

  1. Amputation-free survival

    Time frame: 18 months

    The data for Primary outcome will be collected throughout the first 18 months of the study. The assessed parameters will include amputation-free survival in order to verify the safety and efficacy of the treatment.

Secondary outcomes

  1. Tissue perfusion parameters

    Time frame: 4 years

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Increase of the monitored parameters of the tissue perfusion measured with LDP-Periflux 5000 (Perimed), i.e. increase of the ABI - ankle-brachial index, TP - toe pressure, TBI- Toe Brachial index and TcpO2- transcutaneous oxygen pressure.
    • Decrease of the SPP perfusion parameter - skin perfusion pressure reflecting an inflammatory activity of the affected limb.

  2. Clinical outcome classification

    Time frame: 4 years

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Improvement of the Rutherford scale of CLI

  3. Functional angiogenesis imaging outcome

    Time frame: 4 years

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Increase of the number and quality of newly created vessels measured according to digital subtraction angiography (DSA) or MR-angiography (in allergic patients)

  4. Quality of life outcome

    Time frame: 4 years

    The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.

    • Measurable decrease of pain measured on the scale and QOL questionnaire (RAND-36).
    • Healing of the defect or gangrene (size and state of the wound)

Other outcomes

  1. Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.

    Time frame: 24 months

    The immune response of study subjects will be monitored following the transplantation of stem cells, together with the periphery lymphocyte function (T-cells, B-cells, NK-cells).

    Immune response parameters, (i.e. parameters of lymphocytar blastic transformation)

  2. Metabolic response

    Time frame: 24 months

    The following laboratory parameters throughout the clinical trial:

    • liver and kidney function
    • lipid spectra

  3. Blood glucose and pancreatic function response

    Time frame: 24 months

    The following parameters will be monitored in the study subjects:

    • glycHBA1c levels
    • C-peptide

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Ministry of Health, Czech Republic
  • Regional Council of the Moravian-Silesian region, KU MSK

Registry information

Official study title

Randomised Clinical Study of Safety and Efficacy of Autologous Bone Marrow Aspirate Concentrate (BMAC) for No-option_critical Limb Ischemia in Type-II Diabetes Mellitus Patients. (DIALEG)

Acronym: DIALEG

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2013
Registry last updated
Sep 30, 2021

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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