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

NCT02065167 | Completed Phase 2 DMC

• 2 other identifiers: ORTHO -22012-002010-39
• Study Type: interventional
• Target: 26
• Locations: 4 countries
• Sites: 6

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.

Conditions

Avascular Necrosis of the Femoral Head

Keywords

avascular necrosis of femoral head; cell therapy; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• complication rate

  6,12,24,104 weeks

• Progression of disease to the next stage

  12 months

• Amount of necrotic bone in the femoral head in MRI

  12 weeks and 52 weeks

• Pain (VAS)

  6,12,24,52,104 weeks

• serum levels of bone turnover markers

  12 and 24 weeks

Study Arms (1)

Cultured autologous Mesenchymal Cells

EXPERIMENTAL

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

Biological: Cultured autologous Mesenchymal Cells

Interventions

Cultured autologous Mesenchymal Cells 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.

Cultured autologous Mesenchymal Cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (6)

Department of Orthopaedic Surgery, Hôpital Henri Mondor

Créteil, 94000, France

Location

Department of Orthopaedic Surgery, CHU Tours

Tours, 37044, France

Location

University Children's Hospital

Tübingen, 72076, Germany

Location

Department of Orthopaedic Trauma, University of Ulm

Ulm, 8907581, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

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

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 33535589 RESULT

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrique Gomez-Barrena, Prof

  Universidad Autonoma de Madrid, Hospital la Paz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Chair of orthopaedic surgery

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

DE (2); IT (1); ES (1); FR (2)