Evaluation of safety of celular therapy derived of bone marrow to help bone healing in patients with avascular necrosis of the hip

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

-Age 18 to 65, both sexes
-Early avascular necrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
-Symptomatic osteonecrosis with less than 6 months of evolution
-Able to provide informed consent, and signed informed consent
-Medical health care coverage
-Able to understand and accept the study constraints

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
-Participation in another therapeutic trial in the previous 3 months
-Stages 3 or more (Ficat and Arlet) or III or more (Steinberg) of severe femoral head osteonecrosis, 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.
-Septic arthritis.
-Stress fracture.
-Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, fibrous dysplasia monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
-Any active bisphosphonate treatment or any history of intravenous (IV) treatment.
-History of prior or concurrent diagnosis of HIV-, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR)
-Active hepatitis B or hepatitis C infection at the time of screening. Known allergies to products involved in the production process of MSC.
-History of neoplasia or current neoplasia in any organ.
-Corticoid or immunosuppressive therapy more than one week in the two months prior to study inclusion
-Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery.
-Patients who are in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
-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.
-Serum AST (SGOT)/ALT (SGPT) > 2.5 X (institutional standard range).
-MRI-incompatible internaldevices (pacemakers, aneurysm clips, etc).
-Body mass index (BMI) of 40 kg/m² or greater.
-Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2.
-Insulin dependent diabetes
-Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
-Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or antiangiogenesis treatment.
-Traumatic osteonecrosis.
-Adult in the care of a guardian (Subject legally protected)
-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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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