Clinical trial NCT02065167: Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip
Official title: Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Avascular Necrosis of the Femoral Head
Keywords: avascular necrosis of femoral head
cell therapy
Mesenchymal stem cells
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.

Detailed description: To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.

Eligibility criteria: Inclusion Criteria:

Age 18 to 65, both sexes

* Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
* Sym ptom atic osteonecrosis with less than 6 months of evolution
* Able to provide informed consent, and signed informed consent
* Medical health care coverage

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 m onths
* Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
* Flattening or collapse of the fem oral 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
* 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 m g/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 within 6 months of screening and/or history of illicit drug use.
* Serum AST (SGO T)/ALT (SGPT) \> 2.5 X (institutional standard range).
* MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
* Body mass index (BMI) of 40 kg/m ² 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)
* Im possibility to meet at the appointments for the clinical follow up.

Primary outcomes:
measure: Complication rate
timeFrame: 12 months
Secondary outcomes:
measure: complication rate
timeFrame: 6,12,24,104 weeks
measure: Progression of disease to the next stage
timeFrame: 12 months
measure: Amount of necrotic bone in the femoral head in MRI
timeFrame: 12 weeks and 52 weeks
measure: Pain (VAS)
timeFrame: 6,12,24,52,104 weeks
measure: serum levels of bone turnover markers
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Créteil
country: France
facility: Department of Orthopaedic Surgery, Hôpital Henri Mondor
city: Tours
country: France
facility: Department of Orthopaedic Surgery, CHU Tours
city: Tübingen
country: Germany
facility: University Children's Hospital
city: Ulm
country: Germany
facility: Department of Orthopaedic Trauma, University of Ulm
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Madrid
country: Spain
facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Study officials:
affiliation: Universidad Autonoma de Madrid, Hospital la Paz
name: Enrique Gomez-Barrena, Prof
role: STUDY_CHAIR
References:
citation: Gomez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendano-Sola C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3):508. doi: 10.3390/jcm10030508.