Autologous Bone Marrow Stem Cell Transfer in Patients With Chronical Critical Limb Ischemia and Diabetic Foot

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01232673
First received: November 1, 2010
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Critical Limb Ischemia
Procedure: BMAC application in Critical Limb Ischemia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stem Cell Transfer in Patients With Chronical Critical Limb Ischemia and Diabetic Foot

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • Major limb amputation [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    The measure is the number of major limb amputations within 120 days from the procedure.


Secondary Outcome Measures:
  • Tissue perfusion measurements [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    Measurements of circulatory and blood parameters by laser Doppler flowmetry (TCPO2, TCPCO2, ankle-brachial index - ABI, toe-pressure-TP, toe-brachial index-TBI, skin-persusion pressure-SPP. Peripheral blood tests - white blood cell counts, differention counts, fibrinogen CRP and platelet counts. Bone marrow concentrate analysis to assess the number of CD34 progenitor cells, PQ-50 quality of life questionnaire. Follow-up angiogrwaphy at 120 postoperative days, wound healing measurements.


Enrollment: 96
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMAC treatment active group
Collection 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.
Procedure: BMAC application in Critical Limb Ischemia
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.
Other Names:
  • Critical Limb Ischemia
  • Bone-Marrow Aspiration Concentrate
  • Laser Doppler
No Intervention: Control Study Group
Standard treatment group of patients with CLI after surgical or interventional revascularisation will serve as control.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232673

Sponsors and Collaborators
University Hospital Ostrava
Investigators
Principal Investigator: Vaclav Prochazka, MD, PhD University Hospital Ostrava
  More Information

Publications:
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01232673     History of Changes
Other Study ID Numbers: FNO-99/OVZ/08/006-Dot
Study First Received: November 1, 2010
Last Updated: March 21, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by University Hospital Ostrava:
Critical Limb Ischemia
Bone-Marrow Aspiration Concentrate
Diabetes Mellitus
Major Amputation

Additional relevant MeSH terms:
Diabetic Foot
Ischemia
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Ulcer
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014