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

NCT ID: NCT02065167

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Avascular Necrosis of the Femoral Head

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

20x106 cells per cc in a single administration of 7cc

Group Type: EXPERIMENTAL

Cultured autologous Mesenchymal Cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Prof Enrique Gomez-Barrena

Full Professor and Chair of orthopaedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrique Gomez-Barrena, Prof

Role: STUDY_CHAIR

Universidad Autonoma de Madrid, Hospital la Paz

Locations

Department of Orthopaedic Surgery, Hôpital Henri Mondor

Créteil, , France

Department of Orthopaedic Surgery, CHU Tours

Tours, , France

University Children's Hospital

Tübingen, , Germany

Department of Orthopaedic Trauma, University of Ulm

Ulm, , Germany

Istituto Ortopedico Rizzoli

Bologna, , Italy

Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

Madrid, , Spain

Countries

France; Germany; Italy; Spain

References

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.

Reference Type: RESULT

PMID: 33535589 (View on PubMed)

Other Identifiers

2012-002010-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ORTHO -2

Identifier Type: -

Identifier Source: org_study_id