Stem Cell Therapy for Peripheral Artery Disease

I'm 64 years old with a history of vascular
disease I was told after my last surgery that I will loose my foot and then my leg there is nothing my doctors can do to save my legs.
Will you please help me!
Sincerely,

John Grimm

John, why dont you go to www.cellmedicine.com and try to get tried with autologous stem cells?

Here is the info for the doctors at indiana doing the trial

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

This study is currently recruiting patients.
Verified by Murphy, Michael P., MD June 2005

Sponsors and Collaborators: Murphy, Michael P., MD
Indiana University School of Medicine
Information provided by: Murphy, Michael P., MD
ClinicalTrials.gov Identifier: NCT00113243


Purpose

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.
Condition Intervention Phase
Peripheral Vascular Diseases
Drug: adult stem cells
Phase I


MedlinePlus related topics: Peripheral Vascular Diseases


Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Murphy, Michael P., MD:
Primary Outcome Measures:
Adverse events recorded in the 12 week study period
Serious Adverse events recorded for one year

Secondary Outcome Measures:
Changes in limb perfusion after treatment with stem cells will be assessed with arteriography, blood pressure recordings, oxygen measurements, and wound healing

Total Enrollment: 20
Study start: December 2004; Expected completion: December 2007


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.

Eligibility

Ages Eligible for Study: 21 Years - 80 Years, Genders Eligible for Study: Both
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
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00113243

Michael P Murphy, MD (317) 630-8288 mipmurph@iupui.edu
Julie Lacy, RN (317)962-0138 julacy@iupui.edu


United States, Indiana
Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States; Recruiting
Michael P Murphy, MD 317-630-8288 mipmurph@iupui.edu
Janet Klein, RN (317) 962-0287 jswklein@iupui.edu
Keith L March, MD,PhD, Sub-Investigator



Study chairs or principal investigators

Michael P Murphy, MD, Principal Investigator, Indiana University School of Medicine
More Information

Indiana Center for Vascular Biology and Medicine

General Clinical Research Center at Indiana University School of Medicine

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. 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.

Study ID Numbers: IUPUI 0503-14
Last Updated: June 23, 2005
Record first received: June 6, 2005
ClinicalTrials.gov Identifier: NCT00113243
Health Authority: United States: Food and Drug Administration

Am interested in participating in this study, but I am 82 years old. Would be happy to travel to IUP for follow-up appointments. Is this trial still being done? Would a referral from my cardiovascular surgeon and/or my cardiologist/general practitioner physicians be helpful? Please let me know if this could be arranged.

Charles have you seen the work done by the Institute of Cellular Medicine? They provide this as a fee for service. The website is under Cellmedicine, they put up all the videos