Multicenter Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis. (ARTROCELL)

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status and phase: Active, not recruiting; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Hyaluronic Acid; Drug: Allogenic MSCs; Drug: Autologous MSCs

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05086939

2019-002446-21 (EudraCT Number)

ARTROCELL

2024-514545-11-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

Phase III, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
2. Chronic painful knee of mechanical characteristics.
3. Absence of local or systemic septic process.
4. Hemat imetric and biochemical analysis without significant alterations that contraindicate the treatment.
5. Written informed consent of the patient.
6. The patient is able to understand the nature of the study.
7. Body Mass Index 20-35 Kg/m2.

Exclusion criteria

1. Patient < 18 years old, or legally dependent.
2. Patient > 75 years old.
3. Congenital or developmental 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.
4. Pregnant or breastfeeding women.
5. Neoplastic disease.
6. Intra-articular infiltration of any drug in the 3 months prior to study inclusion.
7. Concurrent participation in another clinical trial or treatment with another investigational product within 30 days prior to study enrollment.
8. Allergy to gentamicin (antibiotic used in the cell culture process ).
9. Other diseases or circumstances that compromise participation in the study according to medical criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Autologous Mesenchymal Stromal Cells (MSC)

Experimental group

Description:

Treatment with 40 millions of autologous autologous adult mesenchymal stem cells from expanded bone marrow administered intra-articularly.

Treatment:

Drug: Autologous MSCs

Allogenic Mesenchymal Stromal Cells (MSC)

Experimental group

Description:

Treatment with 40 millions of adult allogeneic expanded bone marrow mesenchymal stem cells administered intra-articularly.

Treatment:

Drug: Allogenic MSCs

Active Control

Active Comparator group

Description:

Hyaluronic Acid 60mg/3ml administered intra-articularly.

Treatment:

Drug: Hyaluronic Acid