Autologous Bone Marrow Stem Cell Transfer in Patients With Chronical Critical Limb Ischemia and Diabetic Foot
1 other identifier
interventional
96
0 countries
N/A
Brief Summary
A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo local transplantation of ABMSCs. The efficacy/safety of this therapy will be assessed by using several endpoints such as (a) prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to assess the limb ischemia and hypoxia the several tests and measurements will be performed pre- and post transplantation at a variety of time intervals. The measurements include: TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin perfusion pressure, ABI-ankle brachial index, LDP-laser Doppler baseline and heat perfusion assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of biochemical and hematological tests of peripheral venous blood sample will be performed.The quality form "EQ-50" will be completed. 8.1 Primary objective: To evaluate an efficacy-safety profile of autologous bone marrow stem cells (ABMSCs) transplantated into chronically and critically ischemic limb (CLI) and into diabetic foot in stage IV Fontaine, Rutherfod 4-6 classification. 8.2 Secondary objectives: 8.2.1 To assess effect of ABMSCs on tissue perfusion of ischemic limb after transplantation by transcutaneous oximetry and the laser Doppler flowmetry using Periflux 5000 system under normal and provocation test conditions. In addition, wound healing of ulcers will be evaluated using a planimetry method from photographs of affected skin taken pre- and post-transplantation. 8.2.2 Relationship between CD 34 progenitor counts separated on gradient-density separation centrifuge from Harvest Technologies and overall effectiveness and safety to treat ischemic limb. 8.3 Priorities: Beside assessment of effectiveness and safety of ABMSCs transplantation ultimate emphasis will be put on avoiding limb amputation. This has significant socioeconomic impact. Therefore this project belongs to the priority programs of clinical research in cardiovascular diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 22, 2013
March 1, 2013
1.1 years
November 1, 2010
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major limb amputation
The measure is the number of major limb amputations within 120 days from the procedure.
120 days
Secondary Outcomes (1)
Tissue perfusion measurements
120 days
Study Arms (2)
BMAC treatment active group
EXPERIMENTALCollection of 240ml from both illiac crests, followed by gradient density centrifugation, resulting in obtaining 40ml of BMAC. This ammount is applied by one ml per injection into the critical limb ischemia along the calf vessels.
Control Study Group
NO INTERVENTIONStandard treatment group of patients with CLI after surgical or interventional revascularisation will serve as control.
Interventions
Collection of 240ml from both illiac crests, followed by gradient density centrifugation, resulting in obtaining 40ml of BMAC (Bone-Marrow Aspiration Concentrate). BMAC is subsequently administered into the ischemic limb along calf vessels.
Eligibility Criteria
You may qualify if:
- patients suffering from chronic and critical limb ischemia according to the TASC classification Rutherford 4-6, Fontaine IV,
- with failed basic conservative and revascularization treatment (surgical or endovascular),
- with age over 18 years,
- with signed informed consent for this procedure,
- without acute CLI that would require early limb amputation.
You may not qualify if:
- patients with estimated survival less than 6 months,
- with known bone marrow diseases,
- with the final stage of renal failure and dialysed,
- with acute stage of severe limb ischemia with severe inflammatory process affecting patient's life which require limb amputation to avert deterioration in clinical condition and death.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Prochazka V, Gumulec J, Jaluvka F, Salounova D, Jonszta T, Czerny D, Krajca J, Urbanec R, Klement P, Martinek J, Klement GL. Cell therapy, a new standard in management of chronic critical limb ischemia and foot ulcer. Cell Transplant. 2010;19(11):1413-24. doi: 10.3727/096368910X514170. Epub 2010 Jun 7.
PMID: 20529449RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vaclav Prochazka, MD, PhD
University Hospital Ostrava
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 2, 2010
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2010
Last Updated
March 22, 2013
Record last verified: 2013-03