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Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip (ORTHO-2)

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ClinicalTrials.gov Identifier: NCT02065167
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Prof Enrique Gomez-Barrena, Universidad Autonoma de Madrid

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.

Condition or disease Intervention/treatment Phase
Avascular Necrosis of the Femoral Head Biological: Cultured autologous Mesenchymal Cells Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 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

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.




Primary Outcome Measures :
  1. Complication rate [ Time Frame: 12 months ]
    Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.


Secondary Outcome Measures :
  1. complication rate [ Time Frame: 6,12,24,104 weeks ]
    Local and general complication rate

  2. Progression of disease to the next stage [ Time Frame: 12 months ]
  3. Amount of necrotic bone in the femoral head in MRI [ Time Frame: 12 weeks and 52 weeks ]
  4. Pain [ Time Frame: 6,12,24,52,104 weeks ]
  5. serum levels of bone turnover markers [ Time Frame: 12 and 24 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065167


Locations
France
Department of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, France, 94000
Department of Orthopaedic Surgery, CHU Tours
Tours, France, 37044
Germany
University Children's Hospital
Tübingen, Germany, 72076
Department of Orthopaedic Trauma, University of Ulm
Ulm, Germany, 8907581
Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Spain
Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Universidad Autonoma de Madrid
Investigators
Study Chair: Enrique Gomez-Barrena, Prof Universidad Autonoma de Madrid, Hospital la Paz

Additional Information:
Responsible Party: Prof Enrique Gomez-Barrena, Full Professor and Chair of orthopaedic surgery, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02065167     History of Changes
Other Study ID Numbers: ORTHO -2
2012-002010-39 ( EudraCT Number )
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Prof Enrique Gomez-Barrena, Universidad Autonoma de Madrid:
avascular necrosis of femoral head
cell therapy
Mesenchymal stem cells

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Femur Head Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases