EUCTR2012-004441-32-ES
Active, Not Recruiting
N/A
Pilot clinical trial to determine the feasibility and safety of MSV * cryopreserved in the treatment of gonartrosis. * MSV = mesenchymal progenitor cells of expanded autologous bone marrow with GMP procedures of IBGM. - MSV-crio
Fundación Teknon0 sitesNovember 29, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación Teknon
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Gonarthrosis of 2nd, 3rd or 4th degrees of Kellgren and Lawrence (Kellgren \& Lawrence, 1957\) assessed by two observers.
- •2\. Chronic painful knee mechanical characteristics.
- •3\. No local or systemic septic process
- •4\. Hematological and biochemical analysis without significant alterations that contraindicate treatment.
- •5\. Written informed consent of the patient.
- •6\. The patient is able to understand the nature of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1
Exclusion Criteria
- •1\. Patient \<18 years, or legally dependent
- •2\. Patient\> 70 years
- •3\. Previous intervention affected knee
- •4\. Intraarticular treatment in the last 6 months.
- •5\. Infection present (for inclusion in the study should not evidenced any signs infectious).
- •6\. Patients with positive serology for HIV 1 and 2, Hepatitis B (HBsAg, Anti\-HCV\-Ab), Hepatitis C (Anti\-HCV\-Ab) and syphilis.
- •7\. Congenital or developmental malformation translate and / or significant deformation of knee problems and condition of application and evaluation of results.
- •8\. Excess weight expressed as body mass index (BMI) greater than 30\.5 (obesity grade II). Being BMI \= weight (kg): (height (m)) 2\.
- •9\. Women who are pregnant or intend to become pregnant, or breastfeeding
- •10\. neoplastic disease
Outcomes
Primary Outcomes
Not specified
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