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

Information source: Universidad Autonoma de Madrid
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Avascular Necrosis of the Femoral Head

Intervention: Cultured autologous Mesenchymal Cells (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Universidad Autonoma de Madrid

Official(s) and/or principal investigator(s):
Enrique Gomez-Barrena, Prof, Study Chair, Affiliation: Universidad Autonoma de Madrid, Hospital la Paz

Overall contact:
Enrique Gomez-Barrena, Prof, Email: enrique.gomezbarrena@uam.es

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Complication rate

Secondary outcome:

complication rate

Progression of disease to the next stage

Amount of necrotic bone in the femoral head in MRI

Pain

serum levels of bone turnover markers

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Enrique Gomez-Barrena, Prof, Email: enrique.gomezbarrena@uam.es

Department of Orthopaedic Surgery, Hôpital Henri Mondor, Créteil 94000, France; Not yet recruiting
Philippe Hernigou, Dr, Email: philippe.hernigou@wanadoo.fr
Philippe Hernigou, Dr, Principal Investigator

Department of Orthopaedic Surgery, CHU Tours, Tours 37044, France; Not yet recruiting
Philippe Rosset, Dr, Email: rosset@med.univ-tours.fr
Philippe Rosset, Dr, Principal Investigator

University Children's Hospital, Tübingen 72076, Germany; Not yet recruiting
Michaela Doering, Dr, Email: michaela.doering@med.uni-tuebingen.de

Department of Orthopaedic Trauma, University of Ulm, Ulm 8907581, Germany; Not yet recruiting
Florian Gebhard, Prof, Email: florian.gebhard@uniklinik-ulm.de
Florian Gebhard, Prof, Principal Investigator

Istituto Ortopedico Rizzoli, Bologna 40136, Italy; Not yet recruiting
Nicola Baldini, Prof, Email: nicola.baldini@ior.it
Nicola Baldini, Prof, Principal Investigator

Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz, Madrid 28046, Spain; Recruiting
Enrique Gomez-Barrena, Prof, Email: enrique.gomezbarrena@uam.es
Enrique Gomez-Barrena, Prof, Principal Investigator

Additional Information

web page of the REBORNE consortium

Starting date: February 2014
Last updated: February 14, 2014

Page last updated: August 23, 2015

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