Patients diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence MedDRA version: 14.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: MSV/PA -células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos GM
Pharmaceutical Form: Living tissue equivalent
INN or Proposed INN: MSV
Current Sponsor
Sponsors
Fundación Teknon
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and safety of the MSV-cryo after cryopreservation process, restoration and recultivation, applied by percutaneous injection in the knee joint, as a treatment for osteoarthritis of the knee, which is realizable by checking each of the procedures in the protocol, including the cost of cell production, and recording any adverse effects related to cellular therapy and that may arise during the duration of the trial, whether or not related there to.;Secondary Objective: To determine the clinical and variations denoting MR images degeneration or, conversely, progression of arthritic process, after 12 months after implantation effected in MSV-cryo the affected joint.;Primary end point(s): The objective is to evaluate the feasibility and safety of the procedure and the medication by recording adverse events;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical improvement and cartilage quality assessed by algofuncionales rates, quality of life and image of the trial on schedule.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactRobert Soler Rich
Fundación Teknon
Outcome results
None listed