NCT01183728

Brief Summary

In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 15, 2015

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

August 13, 2010

Results QC Date

December 17, 2014

Last Update Submit

January 7, 2015

Conditions

Osteoarthritis, KneeKnee Degenerative DiseaseKnee Osteoarthritis

Keywords

Knee degenerative diseaseosteoarthritisgonarthrosisstem cellcellular therapyregenerative therapyMesenchymal stem cellsBone marrowmusculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.

    Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), 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), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)). In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome. VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities.

    0, 3, 6, 12 and 24 months

Secondary Outcomes (1)

  • Indication of Efficacy

    0, 6, 12, 24 months

Study Arms (1)

MSV autologous transplantation

EXPERIMENTAL

Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection

Other: Autologous bone marrow mesenchymal stem cells (MSV)

Interventions

Autologous bone marrow mesenchymal stem cells (MSV)OTHER

Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.

Also known as: MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
MSV autologous transplantation

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Any sign of infection
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Congenital or acquired malformation resulting in significant deformity of the knee 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Teknon Medical Center, ITRT

Barcelona, Barcelona, 08022, Spain

Location

Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Related Publications (2)

  • 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: 23680930RESULT

  • 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: 24887752RESULT

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMusculoskeletal Diseases

Interventions

Genes, mos

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Proto-OncogenesOncogenesGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic Phenomena

Results Point of Contact

Title
Dr. Javier García-Sancho
Organization
Instituto de Biología y Genética Molecular (IBGM)
jgsancho@ibgm.uva.es
+34 98 318 48 27

Study Officials

  • Luis Orozco, MD, PhD

    Fundacion Teknon

    PRINCIPAL INVESTIGATOR

  • Ana Sanchez, MD, PhD

    IBGM, University of Valladolid

    STUDY DIRECTOR

  • Robert Soler, MD

    Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon

    STUDY DIRECTOR

  • Javier Garcia-Sancho, MD, PhD

    IBGM, University of Valladolid

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 18, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

January 15, 2015

Results First Posted

January 15, 2015

Record last verified: 2015-01

Locations

ES(2)