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

Phase 1

• Conditions: Early avascular necrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC); MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: LLTClassification code 10003860Term: Avascular necrosis femoral headSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-002010-39-IT
• Lead Sponsor: niversidad Autónoma de Madrid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-09
• Last Update Posted: 19 March 2018

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
Main Objective: To evaluate the safety and feasibility of the treatment of early avascular necrosis of the femoral head with expanded bone marrow autologous stem cells to enhance bone healing, after core decompression through percutaneous forage;Secondary Objective: To obtain bone healing, without increasing the complication rate, of early avascular necrosis of the femoral head treated by standard care procedures plus percutaneous injection of autologous stem cells derived from bone marrow and expanded under GMP conditions.;Primary end point(s): Safety endpoints include:<br>-Early local complication rate, as the percentage of patients with local complications within three months after surgery.<br>- Global complication rate, as the percentage of patients with local or general complications at 52 weeks<br>;Timepoint(s) of evaluation of this end point: Complication rates at weeks : 6, 12, 24, 52