Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV*).

• Conditions: gonarthrosis (osteoarthritis); MedDRA version: 14.1Level: LLTClassification code 10048794Term: GonarthrosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005321-51-ES
• Lead Sponsor: Parque Científico de la Universidad de Valladolid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-22
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
2. Chronic painful knee mechanical properties.
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient <18 years, or legally dependent
2. Patient> 65 years
3. Affected knee prior involvement in
4. Intraarticular treatment in the last 6 months.
5. Ligament disruption MRI image displayed on
6. Infection present (for inclusion in the study should not evidenced any sign infectious).
7. Congenital malformations or evolutionary translate and / or significant deformation of the knee and condition difficulties of implementation and evaluation of results.
8. Excess weight expressed as body mass index (BMI) 30.5 (obesity class II). As BMI = weight (kg): (height (m)) 2
9. Women who are pregnant or intend to become pregnant, or breastfeeding
10. neoplastic disease
11. immunosuppressive states
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the feasibility and safety of allogeneic MSV applied by percutaneous injection in the knee joint as a treatment for osteoarthritis of the knee;Secondary Objective: ? Identify the clinical findings and MRI images changes denoting anti-inflammation, regeneration or, progression of the arthritic, 12 months after inyection of MSV in the affected joint.<br> ? Compare the effectiveness of the two tested treatments in two arms: hialuronic acids.;Primary end point(s): efficacy by clinical criteria;Timepoint(s) of evaluation of this end point: 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Improvement by MRI;Timepoint(s) of evaluation of this end point: 6 and 12 months