Status:
COMPLETED
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
Lead Sponsor:
Banc de Sang i Teixits
Collaborating Sponsors:
Centro Medico Teknon
Institut de Terapia Regenerativa Tissular
Conditions:
Osteoarthritis, Knee
Knee Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary ...
Eligibility Criteria
Inclusion
- Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
- Chronic knee pain with mechanical characteristics
- Absence of local or systemic septic process
- Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
- Informed Consent form signed by the patient
- The patient is able to understand the nature of the study
Exclusion
- Patients \< 18 years or legally dependent
- Patients \>65 years
- Previous surgery of the knee
- Intraarticular treatment in the past 6 month
- Knee ligament or meniscus rupture observed by MRI
- Any sign of infection
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), 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).
- Pregnant women 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 :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01227694
Start Date
October 1 2010
End Date
January 1 2013
Last Update
December 11 2015
Active Locations (1)
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1
Centro Medico Teknon-ITRT
Barcelona, Spain, 08022