Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

NCT01586312 | Completed Phase 1 Results DMC

• 4 other identifiers: TerCel0042011-005321-51EC11-309MSV_allo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Knee degenerative disease; osteoarthritis; gonarthrosis; stem cell; cellular therapy; regenerative therapy; Mesenchymal stem cells; Bone marrow; musculoskeletal Diseases; Mesenchymal Stromal Cells (allogenic)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)

  up to one year

• Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)

  up to one year

Study Arms (2)

Allogenic mesenchymal stromal cells injection

EXPERIMENTAL

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

Other: Allogenic mesenchymal stromal cells injection

Hyaluronic acid (Durolane)

ACTIVE COMPARATOR

Intraarticular injection of hyaluronic acid (60 mg)

Drug: Hyaluronic Acid

Interventions

Allogenic mesenchymal stromal cells injection OTHER

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

Also known as: MSV, Mesenchymal Stem Cells, MSC

Allogenic mesenchymal stromal cells injection

Hyaluronic Acid DRUG

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

Also known as: Hyaluronic acid, durolane, CE mark:516407

Hyaluronic acid (Durolane)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Sponsors & Collaborators

• Red de Terapia Celular: lead
• University of Valladolid: collaborator
• Sanidad de Castilla y León: collaborator
• Centro Medico Teknon: collaborator

Study Sites (2)

Centro Medico Teknon

Barcelona, Barcelona, 08022, Spain

Location

Hospital Clinico Universitario

Valladolid, Valladolid, 47003, Spain

Location

Related Publications (4)

• Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-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.

  PMID: 21792091 BACKGROUND

• Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-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.

  PMID: 23680930 BACKGROUND

• Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-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. No abstract available.

  PMID: 24887752 BACKGROUND

• Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.

  PMID: 25822648 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Musculoskeletal Diseases

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Professor Javier Garcia-Sancho
• Organization: Instituto de Biología y Genética Molecular (IBGM)

jgsancho@ibgm.uva.es

34 983 423 084

Study Officials

• Javier García-Sancho, MD, PhD

  University of Valladolid, Scientific Park

  STUDY CHAIR

• Aurelio Vega, MD,PhD

  Hospital Clinico Universitario, Valladolid

  STUDY DIRECTOR

• Luis Orozco, MD, PhD

  Centro Médico Teknon, Barcelona

  STUDY DIRECTOR

• Ana Sanchez, MD, PhD

  Director, Cell Production Unit, Parque Científico UVa

  STUDY DIRECTOR

• Jose M Moraleda, MD. PhD

  Virgen de la Arrixaca University Hospital, Murcia, Spain

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 26, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 16, 2015
• Results First Posted: November 6, 2014

Record last verified: 2015-09

Locations

ES (2)