Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Arthritis of Knee; Knee Osteoarthritis; Osteoarthritis, Knee

Treatments: Drug: Hyaluronic Acid; Other: Allogenic mesenchymal stromal cells injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01586312

TerCel004

MSV_allo (Registry Identifier)

EC11-309 (Other Grant/Funding Number)

2011-005321-51 (EudraCT Number)

Details and patient eligibility

About

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
• Chronic knee pain with mechanical characteristics.
• No local or systemic septic process.
• Haematological and biochemical analysis without significant alterations that contraindicate treatment.
• Informed written consent of the patient.
• The patient is able to understand the nature of the study

Exclusion criteria

• Age over 75 or under 18 years or legally dependent
• Present Infection (to be included in the study no signs of infection must be evidenced)
• Congenital or acquired malformation resulting in significant deformity of the knee (varus<10º; valgus<20º) and leading to problems in application or evaluation of results.
• Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
• Women who are pregnant or intend to become pregnant or breast-feeding
• Neoplasia
• Immunosuppressive states
• Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
• Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Allogenic mesenchymal stromal cells injection

Experimental group

Description:

Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.

Treatment:

Other: Allogenic mesenchymal stromal cells injection

Hyaluronic acid (Durolane)

Active Comparator group

Description:

Intraarticular injection of hyaluronic acid (60 mg)

Treatment:

Drug: Hyaluronic Acid