Clinical trial NCT01586312: Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Official title: Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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)
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: University of Valladolid
name: Sanidad de Castilla y León
name: Centro Medico Teknon
First posted: 2012-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to one year
Secondary outcomes:
measure: Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
timeFrame: up to one year
measure: Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
timeFrame: up to one year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: University of Valladolid, Scientific Park
name: Javier García-Sancho, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Clinico Universitario, Valladolid
name: Aurelio Vega, MD,PhD
role: STUDY_DIRECTOR
affiliation: Centro Médico Teknon, Barcelona
name: Luis Orozco, MD, PhD
role: STUDY_DIRECTOR
affiliation: Director, Cell Production Unit, Parque Científico UVa
name: Ana Sanchez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Virgen de la Arrixaca University Hospital, Murcia, Spain
name: Jose M Moraleda, MD. PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.