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
• Interventions: Procedure: bone marrow aspirate

• 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

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem Cell	bone marrow aspirate	Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight. Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.

Trial Locations

Locations (1)

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