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 个研究点开始时间: 2012年11月29日最近更新: 2013年4月15日

试验速览

暂无简介。

•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•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
•11. United immunosuppressive
•12. Simultaneous participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
•13. Other conditions or circumstances that compromise study participation medically

发起方

Fundación Teknon