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 Transplantatio

Phase 1

• Conditions: Osteonecrosis of the Femoral Head; MedDRA version: 20.0Level: PTClassification code 10031264Term: OsteonecrosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10003860Term: Avascular necrosis femoral headSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-000886-35-ES
• Lead Sponsor: Enrique Gomez-Barrena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 7

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
- Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, monostotic or polyostotic fibrous dysplasia, McCune-Albright syndrome and osteopetrosis)
- Any active bisphosphonate treatment (or 3 months before the trial, except in case they are used in the treatment of an acute disorder that requires prompt management, e.g., severe hypercalcemia, severe bone pain).
- Any evidence of HIV, Hepatitis B or Hepatitis C infection (confirmed by serology or PCR)
- Known allergies to products involved in the production process of MSC
- History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening and/or history of illicit drug use
- MRI incompatible internal devices (pacemakers, aneurysm clips, etc.)
- Impossibility to meet at the appointments for the clinical follow up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified