Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

NCT ID: NCT01586312

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Allogenic mesenchymal stromal cells injection

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

Group Type: EXPERIMENTAL

Allogenic mesenchymal stromal cells injection

Intervention Type: 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

Hyaluronic acid (Durolane)

Intraarticular injection of hyaluronic acid (60 mg)

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type: DRUG

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

Interventions

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

Intervention Type: OTHER

Hyaluronic Acid

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

Intervention Type: DRUG

Other Intervention Names

MSV; Mesenchymal Stem Cells; MSC; Hyaluronic acid, durolane, CE mark:516407

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valladolid

OTHER

Sponsor Role: collaborator

Sanidad de Castilla y León

OTHER

Sponsor Role: collaborator

Centro Medico Teknon

OTHER

Sponsor Role: collaborator

Red de Terapia Celular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier García-Sancho, MD, PhD

Role: STUDY_CHAIR

University of Valladolid, Scientific Park

Aurelio Vega, MD,PhD

Role: STUDY_DIRECTOR

Hospital Clinico Universitario, Valladolid

Luis Orozco, MD, PhD

Role: STUDY_DIRECTOR

Centro Médico Teknon, Barcelona

Ana Sanchez, MD, PhD

Role: STUDY_DIRECTOR

Director, Cell Production Unit, Parque Científico UVa

Jose M Moraleda, MD. PhD

Role: STUDY_DIRECTOR

Virgen de la Arrixaca University Hospital, Murcia, Spain

Locations

Centro Medico Teknon

Barcelona, Barcelona, Spain

Hospital Clinico Universitario

Valladolid, Valladolid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21792091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23680930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24887752 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25822648 (View on PubMed)

Related Links

http://www.red-tercel.com

Cell Therapy Network

http://www.ncbi.nlm.nih.gov/mesh/68020370

osteoarthritis, knee

http://www.ncbi.nlm.nih.gov/mesh?term=cell%2C%20mesenchymal%20stem

mesenchymal stem cells

Other Identifiers

2011-005321-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EC11-309

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MSV_allo

Identifier Type: REGISTRY

Identifier Source: secondary_id

TerCel004

Identifier Type: -

Identifier Source: org_study_id