PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

Osteonecrosis of the Femoral Head Clinical Trial

— CSM/ON/2011  

Official title:

PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700920
• Other study ID #: CSM/ON/2011
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2012
• Last updated: March 29, 2017
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 70 years

• Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head

• Stadiums <IIIC ARCO ranking

Exclusion Criteria:

• Those on investigator judgment not in a good position to tolerate the procedure.

• Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)

• Serious illness uncontrolled

• Pregnant women

• Patients with HIV infection +

• Acute infection (in the previous 15 days) or chronic (other than HIV)

• Previous treatments of osteonecrosis

• Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.

• Lack of informed consent or revocation thereof.

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Femoral Head

Intervention

Procedure:
• bone marrow aspirate

Locations

Country	Name	City	State
Spain	University Hospital of Salamanca	Salamanca	Castilla y León

Sponsors (3)

Lead Sponsor	Collaborator
Red de Terapia Celular	Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System

Country where clinical trial is conducted

Spain, 

External Links

•   Salamanca University Foundation
•   Spanish cell therapy network (TerCel)
•   Spanish Health Institute Carlos III