Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113243
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-06-06
Brief Title:
Safety Study of Using Stem Cells to Stimulate Development of New Blood Vessels in Peripheral Vascular Disease
Sponsor:
Murphy Michael P MD
Organization:
Murphy Michael P MD
Study Overview
Official Title:
Phase I Study of Stem Cell Mediated Angiogenesis for Limb Threatening Ischemia
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None