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 Details — Status: Recruiting

Administrative data

• NCT number: NCT00113243
• Other study ID #: IUPUI 0503-14
• Status: Recruiting
• Phase: Phase 1
• First received: June 6, 2005
• Last updated: June 23, 2005
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: June 2005
• Source: Murphy, Michael P., MD
• Contact: Michael P Murphy, MD
• Phone: (317) 630-8288
• Email: mipmurph[@]iupui.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Severe peripheral vascular disease not amenable to bypass or angioplasty

• Age >21 years old

• Normal renal function (creatinine < 1.6)

Exclusion Criteria:

• Congestive heart failure (ejection fraction [EF]<30%)

• History of cancer or myeloproliferative disorders

• Proliferative retinopathy

• Pregnancy

• Cognitively disabled

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

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• adult stem cells

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Murphy, Michael P., MD	Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

March KL, Johnstone BH. Cellular approaches to tissue repair in cardiovascular disease: the more we know, the more there is to learn. Am J Physiol Heart Circ Physiol. 2004 Aug;287(2):H458-63. Review. — View Citation

Rehman J, Li J, Orschell CM, March KL. Peripheral blood "endothelial progenitor cells" are derived from monocyte/macrophages and secrete angiogenic growth factors. Circulation. 2003 Mar 4;107(8):1164-9. — View Citation

Rehman J, Li J, Parvathaneni L, Karlsson G, Panchal VR, Temm CJ, Mahenthiran J, March KL. Exercise acutely increases circulating endothelial progenitor cells and monocyte-/macrophage-derived angiogenic cells. J Am Coll Cardiol. 2004 Jun 16;43(12):2314-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events recorded in the 12 week study period
Primary	Serious Adverse events recorded for one year
Secondary	Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing

External Links

•   General Clinical Research Center at Indiana University School of Medicine
•   Indiana Center for Vascular Biology and Medicine