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Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia

NCT01065337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-05-25

No results posted yet for this study

Summary

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.

Conditions

  • Diabetic Foot

Interventions

BIOLOGICAL

tissue repair cells (TRC)

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

BIOLOGICAL

bone marrow stem cells (BMC)

bone marrow stem cells

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Diethelm Tschoepe, Prof Dr Dr · Herz- und Diabeteszentrum NRW

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Germany

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 NCT01065337 on ClinicalTrials.gov