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Autologous bone marrow-derived mesenchymal stem cells for early avascular necrosis of the femoral head
2012-002010-39Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2013
- Countries
- 1
- Sponsor
- Universidad Autónoma de Madrid
- Modality
- Stem Cell Therapies → Cell Therapies
- Conditions
- osteonecrosis of the hip
01
Overview
Phase 2, open-label, single-arm trial of autologous bone marrow derived mesenchymal stromal cells in osteonecrosis of the hip, sponsored by Universidad Autónoma de Madrid. Primary endpoint: Safety. Started Dec 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Core decompression plus autologous MSCs
Single treatment arm receiving standard core decompression/percutaneous forage plus autologous bone marrow-derived mesenchymal stem cells.
03
Who it enrols
Adults aged 18 to 65 years with MRI-confirmed early avascular necrosis of the femoral head, corresponding to Ficat and Arlet stages 0, 1, or 2 / Steinberg stages 0, I, IIA, IIB, or IIC. Pregnant or breastfeeding women were excluded, and women of childbearing potential were required to use adequate birth control.
04
Endpoints
Primary
Safety
Secondary
Local and general complication rate
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