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

Sponsor

Universidad Autonoma de Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT02065167

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

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 :

Feb 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Complication rate [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

complication rate [6,12,24,104 weeks]
Local and general complication rate
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Orthopaedic Surgery, Hôpital Henri Mondor	Créteil	France	94000
2	Department of Orthopaedic Surgery, CHU Tours	Tours	France	37044
3	University Children's Hospital	Tübingen	Germany	72076
4	Department of Orthopaedic Trauma, University of Ulm	Ulm	Germany	8907581
5	Istituto Ortopedico Rizzoli	Bologna	Italy	40136
6	Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz	Madrid	Spain	28046