Status:
UNKNOWN
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
Lead Sponsor:
Franziskus-Krankenhaus
Collaborating Sponsors:
Klinikum Karlsbad-Langensteinbach
Stiftungsklinikum Boppard
Conditions:
Peripheral Vascular Disease
Diabetic Foot
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
PHASE3
Brief Summary
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arterioscler...
Detailed Description
Peripheral arterial disease (PAD) represents very advanced arteriosclerosis. It is not unusual for this condition to result in limb-threatening ischemia that usually results in amputation of the limb....
Eligibility Criteria
Inclusion
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Age older than 18 years
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
Exclusion
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
- Renal failure on hemodialysis
- Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00434616
Start Date
April 1 2007
End Date
July 1 2011
Last Update
April 6 2011
Active Locations (1)
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1
Franziskus Hospital Berlin Vascular Center
Berlin, State of Berlin, Germany, D 10787