Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-17 @ 12:26 PM
Study NCT ID:
NCT02065167
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2014-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip
Sponsor:
Universidad Autonoma de Madrid
Organization:
Study Overview
Official Title:
Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head
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:
ORTHO-2
Brief Summary:
The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
Detailed Description:
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-002010-39 | EUDRACT_NUMBER | None | View |