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

Phase 2

Completed

• Conditions: Osteonecrosis of the Femoral Head

• Registration Number: NCT01700920
• Lead Sponsor: Red de Terapia Celular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University Hospital of Salamanca; 🇪🇸 Salamanca, Castilla y León, Spain