NCT01643655
Completed
Not Applicable
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
R-Bio1 site in 1 country15 target enrollmentMay 2012
ConditionsAvascular Necrosis of the Femoral Head
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Avascular Necrosis of the Femoral Head
- Sponsor
- R-Bio
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Magnetic Resonance Imaging
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age :18-70, males and females.
- •Subjects who understand and sign the consent form for this study.
- •Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
- •Steinberg stage I, II, ⅢA
- •Patients whose lesion is more than 30% (by Kim's Method)
Exclusion Criteria
- •Patients who have collapsed femoral head
- •Patient has had a Core Decompression or Multiple Drilling in the affected hip
- •Patients who received osteoporosis medicines and parathyroid hormone drugs
- •Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
- •Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
- •Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Positive serology for HIV and hepatitis
- •Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
- •Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
Outcomes
Primary Outcomes
Magnetic Resonance Imaging
Time Frame: 96 weeks
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
Secondary Outcomes
- SPECT/CT(96 weeks)
- Hip X-ray(96 weeks)
- HHS (Harris Hip Score)(96 weeks)
- WOMAC (Western Ontario and McMaster Universities) Index(96 weeks)
- UCLA (University of California Los Angeles) hip questionnaire(96 weeks)
- Safety evaluation(96 weeks)
Study Sites (1)
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