Clinical Trials Logo
  1. Home
  2. Peripheral Vascular Diseases
  3. NCT00113243

Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease

Peripheral Vascular Diseases Clinical Trial

Official title:
Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia

Clinical Trial Summary

The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

Clinical Trial Description

Presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. For patients with limb threatening ischemia the only option for relief of rest pain or gangrene is amputation.

There is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. In this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. The procedure will require about 4 hours and the subjects will be admitted to the Indiana University Medical Center overnight. The follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00113243
Study type Interventional
Source Murphy, Michael P., MD
Contact Michael P Murphy, MD
Phone (317) 630-8288
Email mipmurph@iupui.edu
Status Recruiting
Phase Phase 1
Start date December 2004
Completion date December 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT00536796 - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets N/A
Completed NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Phase 1/Phase 2
Recruiting NCT00173602 - The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients N/A
Completed NCT00228384 - GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study Phase 4
Completed NCT00163267 - Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel Phase 2/Phase 3
Completed NCT00106327 - Improving Functioning in Peripheral Arterial Disease N/A
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00000614 - Prevention of Recurrent Venous Thromboembolism (PREVENT) Phase 3
Completed NCT00005392 - Epidemiology of Venous Disease N/A
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00541307 - GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) N/A
Completed NCT00520312 - Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease N/A
Terminated NCT00504088 - Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia Phase 4
Completed NCT00533104 - Cell Therapy in Chronic Limb Ischemia Phase 1/Phase 2
Enrolling by invitation NCT05459818 - Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
Completed NCT03875846 - Intraoperative Simultaneous Pressure Guided Revascularization Study
Active, not recruiting NCT05110677 - Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
Active, not recruiting NCT02856230 - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Phase 2/Phase 3