PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells (CSM/ON/2011)

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 2

Conditions: Osteonecrosis of the Femoral Head

Treatments: Procedure: bone marrow aspirate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01700920

CSM/ON/2011

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Mesenchymal Stem Cell

Experimental group

Description:

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.

Treatment:

Procedure: bone marrow aspirate