Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282646
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2006-01-25
Brief Title:
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease PAOD
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with peripheral artery disease stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy autologous bone marrow cells in a randomized placebo controlled trial
Detailed Description:
Main goal
Improvement of limb perfusion Ankle brachial index
Secondary aims
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation TCO2 Minor or major amputation
Improvement of limb perfusion Ankle brachial index
Secondary aims
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation TCO2 Minor or major amputation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PROVASA | None | None | None |