Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

Summary

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.

Conditions

• Osteoarthritis, Knee
• Arthritis of Knee
• Knee Osteoarthritis

Interventions

OTHER

Allogenic mesenchymal stromal cells injection

Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency

DRUG

Hyaluronic Acid

Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Sponsors & Collaborators

• University of Valladolid

  collaborator OTHER

• Sanidad de Castilla y León

  collaborator OTHER

• Centro Medico Teknon

  collaborator OTHER

• Red de Terapia Celular

  lead INDUSTRY

Principal Investigators

• Javier García-Sancho, MD, PhD · University of Valladolid, Scientific Park

• Aurelio Vega, MD,PhD · Hospital Clinico Universitario, Valladolid

• Luis Orozco, MD, PhD · Centro Médico Teknon, Barcelona

• Ana Sanchez, MD, PhD · Director, Cell Production Unit, Parque Científico UVa

• Jose M Moraleda, MD. PhD · Virgen de la Arrixaca University Hospital, Murcia, Spain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-12-31

Completion

2014-06-30

Countries

• Spain

Study Locations