Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in patients with knee osteoarthritis.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Knee osteoarthritis; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859

• Registration Number: EUCTR2019-002446-21-ES
• Lead Sponsor: IBSAL (Instituto de Investigación Biomédica de Salamanca)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-10
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis.
2. Chronic painful knee of mechanical characteristics.
3. Absence of local or systemic septic process.
4. Hematological and biochemical analysis without significant alterations that contraindicate the treatment.
5. Informed written consent of the patient.
6. The patient is able to understand the nature of the study.
7. NEGATIVE Serologies: RPR, HIV, HBV, HCV and HCV PCR, in the 30 days prior to bone marrow extraction.
8. Body Mass Index 20-35 Kg / m2.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Patient <18 years, or legally dependent.
2. Patient> 75 years.
3. Present infection (to be included in the study, no infectious signs should be evidenced).
4. Congenital or evolutionary diseases that translate malformation and / or significant deformations of the knee (varus <10º; valgus <20º) and condition difficulties of application and evaluation of the results.
5. Weight overload expressed in body mass index (BMI) greater than 30.5 (grade II obesity). Being BMI = mass (Kg): (height (m)) 2.
6. Women who are pregnant or pretend to be pregnant or breastfeeding.
7. Neoplastic disease.
8. Primary or secondary immunosuppression.
9. Intra-articular infiltration of any drug in the 3 months prior to inclusion in the study.
10. Simultaneous participation in another clinical trial or treatment with another product under investigation in the 30 days prior to inclusion in the study.
11. Other pathologies or circumstances that compromise participation in the study according to medical criteria.

Study & Design

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