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)
This study is currently recruiting participants.
Verified October 2012 by Red de Terapia Celular
Sponsor:
Red de Terapia Celular
Collaborators:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01700920
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteonecrosis of the Femoral Head |
Procedure: bone marrow aspirate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells |
Resource links provided by NLM:
Further study details as provided by Red de Terapia Celular:
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2012 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mesenchymal Stem Cell
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. |
Procedure: bone marrow aspirate |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700920
Locations
| Spain | |
| University Hospital of Salamanca | Recruiting |
| Salamanca, Castilla y León, Spain, 37007 | |
| Contact: Juan F Blanco, Doctor +34 923 291 100 juanfblanco@telefonica.net | |
| Principal Investigator: Fermín M Sánchez-Guijo, MD | |
| Principal Investigator: Juan F Blanco, MD | |
Sponsors and Collaborators
Red de Terapia Celular
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
More Information
Additional Information:
No publications provided
| Responsible Party: | Red de Terapia Celular |
| ClinicalTrials.gov Identifier: | NCT01700920 History of Changes |
| Other Study ID Numbers: | CSM/ON/2011 |
| Study First Received: | October 2, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Spain: Ethics Committee Spain: Ministry of Health Spain: Spanish Agency of Medicines |
Keywords provided by Red de Terapia Celular:
|
Osteonecrosis of the femoral head Stem Cell Mesenchymal Stem Cells Femoral Head |
Additional relevant MeSH terms:
|
Osteonecrosis Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013