Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip

Avascular Necrosis of the Femoral Head Clinical Trial

— ORTHO-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065167
• Other study ID #: ORTHO -2
• Secondary ID: 2012-002010-39
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2021
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

Biological:
• Cultured autologous Mesenchymal Cells
Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.

Locations

Country	Name	City	State
France	Department of Orthopaedic Surgery, Hôpital Henri Mondor	Créteil
France	Department of Orthopaedic Surgery, CHU Tours	Tours
Germany	University Children's Hospital	Tübingen
Germany	Department of Orthopaedic Trauma, University of Ulm	Ulm
Italy	Istituto Ortopedico Rizzoli	Bologna
Spain	Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

References & Publications (1)

Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendaño-Solá C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Sa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.	12 months
Secondary	complication rate	Local and general complication rate	6,12,24,104 weeks
Secondary	Progression of disease to the next stage		12 months
Secondary	Amount of necrotic bone in the femoral head in MRI		12 weeks and 52 weeks
Secondary	Pain (VAS)		6,12,24,52,104 weeks
Secondary	serum levels of bone turnover markers		12 and 24 weeks