Osteonecrosis of the Femoral Head MedDRA version: 20.0 Level: PT Classification code 10031264 Term: Osteonecrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10003860 Term: Avascular necrosis femoral head System Orga
Conditions
Interventions
Product Name: Cultured mesenchymal stem cells from bone marrow isolation
Product Code: BM-MSCs
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Allogenic MESENCHYMAL STEM CELLS
Curr
Sponsors
Enrique Gomez-Barrena
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, feasibility and preliminary efficacy of bone marrow-derived allogenic MSCs use in the treatment of osteonecrosis of femoral head (ONFH), with placement at necrosis site;Secondary Objective: To obtain bone regeneration maintaining head sphericity and/or avoiding progression of femoral head collapse, without increasing the complication rate, in femoral heads with symptomatic osteonecrosis of femoral head (ONFH);Primary end point(s): - Early local complication rate, as the percentage of patients with local complications within 12 weeks after surgery - Global complication rate, as the percentage of patients with local or general complications at 52 weeks.;Timepoint(s) of evaluation of this end point: 12 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Local and general complication rate at 12, 24 and 104 weeks - Rate of bone healing, as the percentage of patients without clinical and radiological progression at 52 weeks. - Rate of patients with no clinical progression to the next stage (defined as 0 to 1, 1 to 2, 2 to 3 and 3 to 4) at 52 weeks, particularly assessing the progression to femoral head flattening (Steinberg IV and over).. - Rate of patients with no radiological or MRI progression at 6 weeks (X-ray), 12 weeks (X-ray, MRI), 24 weeks X-ray), and 52 weeks (X-ray, MRI). - Amount of necrotic bone in the femoral head at 12 weeks and 52 weeks in MRI, compared with preoperative status. - Changes in serum levels of bone turnover markers (in a centralized laboratory) at 12, 24 and 52 weeks after treatment, compared with preoperative levels. - Pain assessed by Likert Scale (1 to 10) at 12, 24 and 52 weeks;Timepoint(s) of evaluation of this end point: 12, 24, 52 or 104 weeks | — |
Countries
Spain
Contacts
Public ContactConcepcion Payares-Herrera
H.U. Puerta de Hierro
Outcome results
None listed