Trial Outcomes & Findings for Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (NCT NCT01183728)
NCT ID: NCT01183728
Last Updated: 2015-01-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
0, 3, 6, 12 and 24 months
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
MSV Autologous Transplantation
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.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
Baseline characteristics by cohort
| Measure |
MSV Autologous Transplantation
n=12 Participants
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.
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Age, Customized
>=18 and <=70 years
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9 participants
n=5 Participants
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Age, Customized
>70 years
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3 participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Region of Enrollment
Spain
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12 participants
n=5 Participants
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Number of Participants with Major Surgical History on Treated Knee
With Major Surgical History on Treated Knee
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9 participants
n=5 Participants
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Number of Participants with Major Surgical History on Treated Knee
Without Major Surgical History on Treated Knee
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3 participants
n=5 Participants
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Number of Participants with 4th grade osteoarthritis.
With 4th grade osteoarthritis
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5 participants
n=5 Participants
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Number of Participants with 4th grade osteoarthritis.
With 2nd or 3th grade osteoarthritis
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 0, 3, 6, 12 and 24 monthsClinical 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.
Outcome measures
| Measure |
MSV Autologous Transplantation
n=12 Participants
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.
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-DA. 6 months
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24.8 units on a scale
Standard Deviation 6.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-DA. 12 months
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15.4 units on a scale
Standard Deviation 3.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-DA. 24 months
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15.8 units on a scale
Standard Deviation 12.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-SP. 0 months
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56.1 units on a scale
Standard Deviation 5.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-SP. 3 months
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29.8 units on a scale
Standard Deviation 7.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-SP. 6 months
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28.9 units on a scale
Standard Deviation 6.4
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-SP. 12 months
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18.5 units on a scale
Standard Deviation 3.9
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-SP. 24 months
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18.9 units on a scale
Standard Deviation 5.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Pain. 0 months
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24.2 units on a scale
Standard Deviation 4.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Pain. 12 months
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5.8 units on a scale
Standard Deviation 1.6
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Pain. 24 months
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11.7 units on a scale
Standard Deviation 4.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Rigidity. 0 months
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10.4 units on a scale
Standard Deviation 3.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Rigidity. 12 months
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5.2 units on a scale
Standard Deviation 3.2
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Rigidity. 24 months
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8.3 units on a scale
Standard Deviation 4.2
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Function loss. 0 months
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19.1 units on a scale
Standard Deviation 3.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Function loss. 12 months
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9.4 units on a scale
Standard Deviation 3.2
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Function loss. 24 months
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12.1 units on a scale
Standard Deviation 6.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Total. 0 months
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19.4 units on a scale
Standard Deviation 3.6
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Total. 12 months
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8.3 units on a scale
Standard Deviation 2.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
WOMAC - Total. 24 months
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11.7 units on a scale
Standard Deviation 5.4
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Lequesne. 0 months
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45.1 units on a scale
Standard Deviation 5.6
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Lequesne. 12 months
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14.9 units on a scale
Standard Deviation 4.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Lequesne. 24 months
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13.9 units on a scale
Standard Deviation 4.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Function. Basal
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18.8 units on a scale
Standard Deviation 22.9
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Function. 3 months
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21.0 units on a scale
Standard Deviation 27.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Function. 6 months
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25.7 units on a scale
Standard Deviation 28.4
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Function. 12 months
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25.1 units on a scale
Standard Deviation 22.4
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Role. Basal
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31.1 units on a scale
Standard Deviation 24.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Role. 3 months
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36.9 units on a scale
Standard Deviation 26.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Role. 6 months
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38.6 units on a scale
Standard Deviation 26.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Physical Role. 12 months
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47.7 units on a scale
Standard Deviation 13.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Bodily Pain. Basal
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27.2 units on a scale
Standard Deviation 19.6
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Bodily Pain. 3 months
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25.7 units on a scale
Standard Deviation 17.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Bodily Pain. 6 months
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31.8 units on a scale
Standard Deviation 22.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Bodily Pain. 12 months
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36.3 units on a scale
Standard Deviation 23.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. General Health. Basal
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64.8 units on a scale
Standard Deviation 16.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. General Health. 3 months
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58.5 units on a scale
Standard Deviation 17.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. General Health. 6 months
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65.2 units on a scale
Standard Deviation 22.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. General Health. 12 months
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63.3 units on a scale
Standard Deviation 20.9
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Vitality. Basal
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58.3 units on a scale
Standard Deviation 23.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Vitality. 3 months
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53.9 units on a scale
Standard Deviation 26.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Vitality. 6 months
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56.8 units on a scale
Standard Deviation 18.2
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Vitality. 12 months
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47.7 units on a scale
Standard Deviation 13.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Social Function. Basal
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48.8 units on a scale
Standard Deviation 22.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Social Function. 3 months
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47.3 units on a scale
Standard Deviation 25.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Social Function. 6 months
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53.0 units on a scale
Standard Deviation 24.8
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Social Function. 12 months
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44.2 units on a scale
Standard Deviation 18.2
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Role Emotional. Basal
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54.2 units on a scale
Standard Deviation 5.1
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Role Emotional. 3 months
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53.2 units on a scale
Standard Deviation 4.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Role Emotional. 6 months
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53.2 units on a scale
Standard Deviation 4.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Role Emotional. 12 months
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50.8 units on a scale
Standard Deviation 9.0
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Mental Health. Basal
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68.1 units on a scale
Standard Deviation 18.7
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Mental Health. 3 months
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61.0 units on a scale
Standard Deviation 22.6
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Mental Health. 6 months
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61.8 units on a scale
Standard Deviation 19.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
SF-36. Mental Health. 12 months
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63.3 units on a scale
Standard Deviation 22.3
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-DA. 0 months
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46.9 units on a scale
Standard Deviation 7.5
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Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.
Knee pain VAS-DA. 3 months
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25.1 units on a scale
Standard Deviation 6.8
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SECONDARY outcome
Timeframe: 0, 6, 12, 24 monthsClinical 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.
Outcome measures
| Measure |
MSV Autologous Transplantation
n=12 Participants
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.
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Indication of Efficacy
MRI T2 mapping. 6 months
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15.4 percentage of values
Standard Deviation 7
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Indication of Efficacy
MRI T2 mapping. 0 months
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19.5 percentage of values
Standard Deviation 7.9
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Indication of Efficacy
MRI T2 mapping. 12 months
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14.3 percentage of values
Standard Deviation 6.3
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Indication of Efficacy
MRI T2 mapping. 24 months
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13 percentage of values
Standard Deviation 5.8
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Adverse Events
MSV Autologous Transplantation
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MSV Autologous Transplantation
n=12 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Post implantation pain
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50.0%
6/12 • Number of events 8 • 24 months
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Musculoskeletal and connective tissue disorders
Joint swelling
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25.0%
3/12 • Number of events 3 • 24 months
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Musculoskeletal and connective tissue disorders
Unexpected inflammation with joint effusion
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25.0%
3/12 • Number of events 3 • 24 months
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Musculoskeletal and connective tissue disorders
Contralateral knee pain
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8.3%
1/12 • Number of events 1 • 24 months
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Musculoskeletal and connective tissue disorders
Lumar pain
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16.7%
2/12 • Number of events 4 • 24 months
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Musculoskeletal and connective tissue disorders
hamstring tendinitis
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8.3%
1/12 • Number of events 1 • 24 months
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Surgical and medical procedures
Contralateral knee surgery
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8.3%
1/12 • Number of events 1 • 24 months
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Surgical and medical procedures
Dental implant
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8.3%
1/12 • Number of events 1 • 24 months
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Infections and infestations
Influenza
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8.3%
1/12 • Number of events 1 • 24 months
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Gastrointestinal disorders
Gluten and lactose intolerance
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8.3%
1/12 • Number of events 1 • 24 months
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Additional Information
Dr. Javier García-Sancho
Instituto de Biología y Genética Molecular (IBGM)
Phone: +34 98 318 48 27
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place