Status:
COMPLETED
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Fundacion Teknon, Centro Medico Teknon, Barcelona
University of Valladolid
Conditions:
Osteoarthritis, Knee
Knee Degenerative Disease
Eligibility:
All Genders
18-76 years
Phase:
PHASE1
PHASE2
Brief Summary
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothes...
Detailed Description
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has b...
Eligibility Criteria
Inclusion
- Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
- Chronic knee pain with mechanical characteristics.
- No local or systemic septic process.
- Haematological and biochemical analysis without significant alterations that contraindicate treatment.
- Informed written consent of the patient.
- The patient is able to understand the nature of the study
Exclusion
- Age over 75 or under 18 years or legally dependent
- Any sign of infection
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
- Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
- Women who are pregnant or intend to become pregnant or breast-feeding
- Neoplasia
- Immunosuppressive states
- Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01183728
Start Date
May 1 2010
End Date
September 1 2014
Last Update
January 15 2015
Active Locations (2)
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1
Teknon Medical Center, ITRT
Barcelona, Barcelona, Spain, 08022
2
Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid
Valladolid, Valladolid, Spain, 47003