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Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)

Primary Purpose

Osteoarthritis, Knee, Arthritis of Knee, Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Allogenic mesenchymal stromal cells injection

Hyaluronic Acid

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee degenerative disease, osteoarthritis, gonarthrosis, stem cell, cellular therapy, regenerative therapy, Mesenchymal stem cells, Bone marrow, musculoskeletal Diseases, Mesenchymal Stromal Cells (allogenic)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Medico Teknon
Hospital Clinico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Allogenic mesenchymal stromal cells injection

Hyaluronic acid (Durolane)

Arm Description

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

Intraarticular injection of hyaluronic acid (60 mg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01586312

First Posted

April 23, 2012

Last Updated

September 26, 2015

Sponsor

Red de Terapia Celular

Collaborators

University of Valladolid, Sanidad de Castilla y León, Centro Medico Teknon

1. Study Identification

Unique Protocol Identification Number

NCT01586312

Brief Title

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

Acronym

MSV_allo

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Red de Terapia Celular

Collaborators

University of Valladolid, Sanidad de Castilla y León, Centro Medico Teknon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allogenic mesenchymal stromal cells injection

Arm Type

Experimental

Arm Description

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

Arm Title

Hyaluronic acid (Durolane)

Arm Type

Active Comparator

Arm Description

Intraarticular injection of hyaluronic acid (60 mg)

Intervention Type

Other

Intervention Name(s)

Allogenic mesenchymal stromal cells injection

Other Intervention Name(s)

MSV, Mesenchymal Stem Cells, MSC

Intervention Description

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

Drug

Intervention Name(s)

Hyaluronic Acid

Other Intervention Name(s)

Hyaluronic acid, durolane, CE mark:516407

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Description

Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months

Time Frame

Up to one year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to one year

Title

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

Description

Time Frame

up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials: