Status:
COMPLETED
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
Ministry of Health, Czech Republic
Regional Council of the Moravian-Silesian region, KU MSK
Conditions:
Critical Lower Limb Ischemia
Type-2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 wi...
Detailed Description
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 decreas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01818310
Start Date
September 1 2012
End Date
October 1 2018
Last Update
September 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Ostrava
Ostrava, Czechia, 708 52