Clinical trial to determine the feasibility and safety of MSV cryopreserved in the treatment of gonartrosis

Conditions: Patients diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence
MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-004441-32-ES

Lead Sponsor: Fundación Teknon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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
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