Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

Knee Osteoarthritis Clinical Trial

— MSV_allo  

Official title:

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586312
• Other study ID #: TerCel004
• Secondary ID: 2011-005321-51EC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 23, 2012
• Last updated: September 26, 2015
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis of Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)

Locations

Country	Name	City	State
Spain	Centro Medico Teknon	Barcelona
Spain	Hospital Clinico Universitario	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Red de Terapia Celular	Centro Medico Teknon, Sanidad de Castilla y Leon (SACYL), University of Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentís J, Sánchez A, García-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013 Jun 27;95(12):1535-41. doi: 10.1097/TP.0b013e318291a2da. — View Citation

Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentís J, Sánchez A, García-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014 Jun 15;97(11):e66-8. doi: 10.1097/TP.0000000000000167. — View Citation

Orozco L, Soler R, Morera C, Alberca M, Sánchez A, García-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months	Up to one year	Yes
Secondary	Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)	Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.; WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.; SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.; The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.; LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).; All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.; Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.	up to one year	No
Secondary	Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)	Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.; Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.	up to one year	No

External Links

•   Cell Therapy Network
•   mesenchymal stem cells
•   MSV providing
•   osteoarthritis, knee