Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease
NCT ID: NCT00113243
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2004-12-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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adult stem cells
Eligibility Criteria
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Inclusion Criteria
* Age \>21 years old
* Normal renal function (creatinine \< 1.6)
Exclusion Criteria
* History of cancer or myeloproliferative disorders
* Proliferative retinopathy
* Pregnancy
* Cognitively disabled
21 Years
80 Years
ALL
No
Sponsors
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Indiana University School of Medicine
OTHER
Murphy, Michael P., MD
INDIV
Principal Investigators
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Michael P Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Michael P Murphy, MD
Role: primary
Janet Klein, RN
Role: backup
References
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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. doi: 10.1016/j.jacc.2004.02.049.
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. doi: 10.1152/ajpheart.00343.2004. No abstract available.
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. doi: 10.1161/01.cir.0000058702.69484.a0.
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.
Related Links
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General Clinical Research Center at Indiana University School of Medicine
Other Identifiers
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IUPUI 0503-14
Identifier Type: -
Identifier Source: org_study_id