Back to resultsPHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells (CSM/ON/2011)
Primary Purpose
Osteonecrosis of the Femoral Head
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
bone marrow aspirate
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis of the Femoral Head focused on measuring Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head
Eligibility 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.
Sites / Locations
- University Hospital of Salamanca
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal Stem Cell
Arm 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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01700920
First Posted
October 2, 2012
Last Updated
March 29, 2017
Sponsor
Red de Terapia Celular
Collaborators
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
1. Study Identification
Unique Protocol Identification Number
NCT01700920
Brief Title
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
Collaborators
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis of the Femoral Head
Keywords
Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stem Cell
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
bone marrow aspirate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Hospital of Salamanca
City
Salamanca
State/Province
Castilla y León
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.red-tercel.com
Description
Spanish cell therapy network (TerCel)
URL
http://fundacion.usal.es
Description
Salamanca University Foundation
URL
http://www.isciii.es
Description
Spanish Health Institute Carlos III
Learn more about this trial
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
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