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Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (KDD&MSV)

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ClinicalTrials.gov Identifier: NCT01183728
Recruitment Status : Completed
First Posted : August 18, 2010
Results First Posted : January 15, 2015
Last Update Posted : January 15, 2015
Sponsor:
Collaborators:
Fundacion Teknon, Centro Medico Teknon, Barcelona
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Institut de Terapia Regenerativa Tissular
EGARSAT Suma Intermutual, Barcelona, Spain
Cetir Sant Jordi, S.a..
Information provided by (Responsible Party):
Red de Terapia Celular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis, Knee
Knee Degenerative Disease
Knee Osteoarthritis
Intervention Other: Autologous bone marrow mesenchymal stem cells (MSV)
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title MSV Autologous Transplantation
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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

Autologous bone marrow mesenchymal stem cells (MSV): 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.

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title MSV Autologous Transplantation
Hide Arm/Group Description

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

Autologous bone marrow mesenchymal stem cells (MSV): 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.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
All included patients met the inclusion criteria and no exclusion criteria.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
>=18 and <=70 years 9
>70 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 12 participants
12
Number of Participants with Major Surgical History on Treated Knee  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
With Major Surgical History on Treated Knee 9
Without Major Surgical History on Treated Knee 3
Number of Participants with 4th grade osteoarthritis.  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
With 4th grade osteoarthritis 5
With 2nd or 3th grade osteoarthritis 7
1.Primary Outcome
Title Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
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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.

Time Frame 0, 3, 6, 12 and 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSV Autologous Transplantation
Hide Arm/Group Description:

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

Autologous bone marrow mesenchymal stem cells (MSV): 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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Knee pain VAS-DA. 0 months 46.9  (7.5)
Knee pain VAS-DA. 3 months 25.1  (6.8)
Knee pain VAS-DA. 6 months 24.8  (6.0)
Knee pain VAS-DA. 12 months 15.4  (3.8)
Knee pain VAS-DA. 24 months 15.8  (12.0)
Knee pain VAS-SP. 0 months 56.1  (5.1)
Knee pain VAS-SP. 3 months 29.8  (7.3)
Knee pain VAS-SP. 6 months 28.9  (6.4)
Knee pain VAS-SP. 12 months 18.5  (3.9)
Knee pain VAS-SP. 24 months 18.9  (5.3)
WOMAC - Pain. 0 months 24.2  (4.1)
WOMAC - Pain. 12 months 5.8  (1.6)
WOMAC - Pain. 24 months 11.7  (4.0)
WOMAC - Rigidity. 0 months 10.4  (3.7)
WOMAC - Rigidity. 12 months 5.2  (3.2)
WOMAC - Rigidity. 24 months 8.3  (4.2)
WOMAC - Function loss. 0 months 19.1  (3.8)
WOMAC - Function loss. 12 months 9.4  (3.2)
WOMAC - Function loss. 24 months 12.1  (6.1)
WOMAC - Total. 0 months 19.4  (3.6)
WOMAC - Total. 12 months 8.3  (2.7)
WOMAC - Total. 24 months 11.7  (5.4)
Lequesne. 0 months 45.1  (5.6)
Lequesne. 12 months 14.9  (4.1)
Lequesne. 24 months 13.9  (4.7)
SF-36. Physical Function. Basal 18.8  (22.9)
SF-36. Physical Function. 3 months 21.0  (27.3)
SF-36. Physical Function. 6 months 25.7  (28.4)
SF-36. Physical Function. 12 months 25.1  (22.4)
SF-36. Physical Role. Basal 31.1  (24.5)
SF-36. Physical Role. 3 months 36.9  (26.5)
SF-36. Physical Role. 6 months 38.6  (26.3)
SF-36. Physical Role. 12 months 47.7  (13.7)
SF-36. Bodily Pain. Basal 27.2  (19.6)
SF-36. Bodily Pain. 3 months 25.7  (17.8)
SF-36. Bodily Pain. 6 months 31.8  (22.1)
SF-36. Bodily Pain. 12 months 36.3  (23.8)
SF-36. General Health. Basal 64.8  (16.8)
SF-36. General Health. 3 months 58.5  (17.5)
SF-36. General Health. 6 months 65.2  (22.5)
SF-36. General Health. 12 months 63.3  (20.9)
SF-36. Vitality. Basal 58.3  (23.3)
SF-36. Vitality. 3 months 53.9  (26.1)
SF-36. Vitality. 6 months 56.8  (18.2)
SF-36. Vitality. 12 months 47.7  (13.7)
SF-36. Social Function. Basal 48.8  (22.7)
SF-36. Social Function. 3 months 47.3  (25.0)
SF-36. Social Function. 6 months 53.0  (24.8)
SF-36. Social Function. 12 months 44.2  (18.2)
SF-36. Role Emotional. Basal 54.2  (5.1)
SF-36. Role Emotional. 3 months 53.2  (4.0)
SF-36. Role Emotional. 6 months 53.2  (4.0)
SF-36. Role Emotional. 12 months 50.8  (9.0)
SF-36. Mental Health. Basal 68.1  (18.7)
SF-36. Mental Health. 3 months 61.0  (22.6)
SF-36. Mental Health. 6 months 61.8  (19.5)
SF-36. Mental Health. 12 months 63.3  (22.3)
2.Secondary Outcome
Title Indication of Efficacy
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Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.

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 percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100.

Time Frame 0, 6, 12, 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSV Autologous Transplantation
Hide Arm/Group Description:

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

Autologous bone marrow mesenchymal stem cells (MSV): 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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percentage of values
MRI T2 mapping. 0 months 19.5  (7.9)
MRI T2 mapping. 6 months 15.4  (7)
MRI T2 mapping. 12 months 14.3  (6.3)
MRI T2 mapping. 24 months 13  (5.8)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MSV Autologous Transplantation
Hide Arm/Group Description

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

Autologous bone marrow mesenchymal stem cells (MSV): 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.

All-Cause Mortality
MSV Autologous Transplantation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MSV Autologous Transplantation
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MSV Autologous Transplantation
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Gastrointestinal disorders   
Gluten and lactose intolerance   1/12 (8.33%)  1
Infections and infestations   
Influenza   1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Post implantation pain  [1]  6/12 (50.00%)  8
Joint swelling  [2]  3/12 (25.00%)  3
Unexpected inflammation with joint effusion   3/12 (25.00%)  3
Contralateral knee pain   1/12 (8.33%)  1
Lumar pain   2/12 (16.67%)  4
hamstring tendinitis   1/12 (8.33%)  1
Surgical and medical procedures   
Contralateral knee surgery   1/12 (8.33%)  1
Dental implant   1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
between days 1 and 6
[2]
Attributable to overload
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Javier García-Sancho
Organization: Instituto de Biología y Genética Molecular (IBGM)
Phone: +34 98 318 48 27
Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01183728     History of Changes
Other Study ID Numbers: TerCel001
Eudra-CT 2009-017405-11 ( Other Grant/Funding Number: RD06/0010/0000 )
Protocol Code ( Registry Identifier: MSV-arthro-2009-01 )
First Submitted: August 13, 2010
First Posted: August 18, 2010
Results First Submitted: December 17, 2014
Results First Posted: January 15, 2015
Last Update Posted: January 15, 2015