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

• ClinicalTrials.gov Identifier: NCT00113243
• Recruitment Status: Unknown
• First Posted: June 7, 2005
• Last Update Posted: June 24, 2005
• Sponsor: Murphy, Michael P., MD
• Collaborator: Indiana University School of Medicine
• Information provided by: Murphy, Michael P., MD

Tracking Information

• First Submitted Date: June 6, 2005
• First Posted Date: June 7, 2005
• Last Update Posted Date: June 24, 2005
• Study Start Date: December 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: June 23, 2005)

• Adverse events recorded in the 12 week study period
• Serious Adverse events recorded for one year

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: June 23, 2005): Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease
• Official Title: Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia
• Brief 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.

Detailed 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Vascular Diseases
• Intervention: Drug: adult stem cells
• Study Arms: Not Provided

Publications *

• 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.
• 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.
• 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.
• Liang TW, Jester A, Motaganahalli RL, Wilson MG, G'Sell P, Akingba GA, Fajardo A, Murphy MP. Autologous bone marrow mononuclear cell therapy for critical limb ischemia is effective and durable. J Vasc Surg. 2016 Jun;63(6):1541-5. doi: 10.1016/j.jvs.2016.01.022. Epub 2016 Mar 23.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: June 23, 2005): 20
• Original Enrollment: Same as current
• Study Completion Date: December 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00113243
• Other Study ID Numbers: IUPUI 0503-14
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Murphy, Michael P., MD
• Collaborators: Indiana University School of Medicine

Investigators

• Principal Investigator: Michael P Murphy, MD; Indiana University School of Medicine

• PRS Account: Murphy, Michael P., MD
• Verification Date: June 2005