EUCTR2018-000886-35-ES
Active, not recruiting
Phase 1
Evaluation of safety, feasibility and preliminary efficacy of MSCs from third party donors in the treatment of patients with osteonecrosis of the femoral head after allogeneic Stem Cell Transplantation (AloFem) - AloFem
Enrique Gomez-Barrena0 sites7 target enrollmentApril 9, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Enrique Gomez-Barrena
- Enrollment
- 7
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age: 8 to 55, both sexes
- •\- Patients having received allogeneic haematological stem cell transplant (HSCT), due to hematologic diseases, in remission. The patient may be or have been under immunosupression.
- •\- Osteonecrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, 2 or 3 or ARCO stages 0, I, IIA, IIB, IIC, IIIA, IIIB, IIIC or Steinberg stages 0, I, II, III.
- •\- Able to provide informed consent, and signed informed consent (by themselves or legal representative)
- •\- Medical health care coverage
- •\- Able to understand and accept the study constraints (by themselves or legal representative)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 3
Exclusion Criteria
- •\- Disease in relapse
- •\- Active infection of any location and aetiology
- •\- Surgical contraindication of any cause
- •\- Pregnancy, breastfeeding women and women who are of childbearing age and not practicing adequate birth control.
- •\- Stage 4 (Ficat and Arlet) or IV and above (Steinberg) or ARCO IV, with severe femoral head osteonecrosis associated to acetabular changes, primarily based on diagnosis by imaging (X\-Rays, MRI)
- •\- Flattening or collapse of the femoral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery
- •\- Any tumour infiltration of the femoral head and/or neck
- •\- Other tumour infiltration with short\-term life risk
- •\- Stress or pathological fracture of the femoral neck
- •\- Traumatic osteonecrosis
Outcomes
Primary Outcomes
Not specified
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