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

NCT01818310 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Critical Lower Limb Ischemia
  • Type-2 Diabetes Mellitus

Interventions

BIOLOGICAL

Group A: Intramuscular

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.

BIOLOGICAL

Group B: Intraarterial

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

BIOLOGICAL

Group C: Intravenous

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

PROCEDURE

Group D: Surgical endovascular treatment with maximum medicamentous treatment

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

Sponsors & Collaborators

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV

  • Regional Council of the Moravian-Silesian region, KU MSK

    collaborator UNKNOWN

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Vaclav Prochazka, MD, PhD, MSc · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-09-30
Completion
2018-10-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818310 on ClinicalTrials.gov