Trial Outcomes & Findings for Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (NCT NCT01586312)
NCT ID: NCT01586312
Last Updated: 2015-10-16
Results Overview
Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to one year
Results posted on
2015-10-16
Participant Flow
30 patients were included between 26/Jul/2012 (Pat. 01) and12/Dic/2012 (Pat. 30).
All patients fulfilled the selection criteria, were randomized and received the assigned medication.
Participant milestones
| Measure |
Allogenic Mesenchymal Stromal Cells
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Baseline characteristics by cohort
| Measure |
Allogenic Mesenchymal Stromal Cells
n=15 Participants
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
n=15 Participants
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.60 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
57.33 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
56.97 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one yearPopulation: Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC). and Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments.
Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
Outcome measures
| Measure |
Allogenic Mesenchymal Stromal Cells
n=15 Participants
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
n=15 Participants
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
14 participants
|
13 participants
|
SECONDARY outcome
Timeframe: up to one yearClinical 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.
Outcome measures
| Measure |
Allogenic Mesenchymal Stromal Cells
n=15 Participants
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
n=15 Participants
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
|---|---|---|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - General 6 months
|
-13.03 units on a scale
Standard Deviation 18.2
|
-5.47 units on a scale
Standard Deviation 15.9
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Stiffness 3 months
|
-4.77 units on a scale
Standard Deviation 30.5
|
-1.93 units on a scale
Standard Deviation 25.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Stiffness 6 months
|
-3.17 units on a scale
Standard Deviation 23.8
|
-2.87 units on a scale
Standard Deviation 23.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Pain 3 months
|
-10.01 units on a scale
Standard Deviation 23.7
|
-4.27 units on a scale
Standard Deviation 17.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Pain 6 months
|
-13.02 units on a scale
Standard Deviation 19.0
|
-5.97 units on a scale
Standard Deviation 12.1
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Pain 12 months
|
-16.30 units on a scale
Standard Deviation 23
|
-6.36 units on a scale
Standard Deviation 15.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - General Health 3 months
|
0.12 units on a scale
Standard Deviation 22.5
|
0.39 units on a scale
Standard Deviation 16.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - General Health 6 months
|
10.64 units on a scale
Standard Deviation 22.8
|
2.11 units on a scale
Standard Deviation 21.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - General Health 12 month
|
5.24 units on a scale
Standard Deviation 27.9
|
2.51 units on a scale
Standard Deviation 21.1
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical function 3 m
|
10.00 units on a scale
Standard Deviation 36.4
|
18.33 units on a scale
Standard Deviation 30.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical function 6 m
|
13.33 units on a scale
Standard Deviation 26.5
|
11.67 units on a scale
Standard Deviation 32.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical function 12 m
|
21.67 units on a scale
Standard Deviation 22.9
|
20.00 units on a scale
Standard Deviation 30.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical rol 3 months
|
2.50 units on a scale
Standard Deviation 21.2
|
4.17 units on a scale
Standard Deviation 31.2
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical rol 6 months
|
6.67 units on a scale
Standard Deviation 38.9
|
9.17 units on a scale
Standard Deviation 29.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical rol 12 months
|
5.00 units on a scale
Standard Deviation 34.0
|
6.67 units on a scale
Standard Deviation 30.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Emotional rol 3 months
|
-1.67 units on a scale
Standard Deviation 22.6
|
-5.83 units on a scale
Standard Deviation 24.5
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Emotional rol 6 months
|
5.83 units on a scale
Standard Deviation 33.0
|
1.67 units on a scale
Standard Deviation 15.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Emotional rol 12 months
|
0.00 units on a scale
Standard Deviation 31.0
|
0.83 units on a scale
Standard Deviation 18.0
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Body pain 3 months
|
10.0 units on a scale
Standard Deviation 26.4
|
5.00 units on a scale
Standard Deviation 28.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Body pain 6 months
|
15.00 units on a scale
Standard Deviation 28.0
|
11.67 units on a scale
Standard Deviation 26.5
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Body pain 12 months
|
13.33 units on a scale
Standard Deviation 36.4
|
13.33 units on a scale
Standard Deviation 24.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 3 months
|
-5.83 units on a scale
Standard Deviation 24.5
|
3.33 units on a scale
Standard Deviation 19.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 6 months
|
3.33 units on a scale
Standard Deviation 25.2
|
3.33 units on a scale
Standard Deviation 19.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 12 months
|
0.00 units on a scale
Standard Deviation 14.2
|
5.00 units on a scale
Standard Deviation 18.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Vitality 3 months
|
-6.67 units on a scale
Standard Deviation 37.2
|
1.67 units on a scale
Standard Deviation 25.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Vitality 6 months
|
-1.67 units on a scale
Standard Deviation 33.4
|
1.67 units on a scale
Standard Deviation 25.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Vitality 12 months
|
-8.33 units on a scale
Standard Deviation 36.2
|
-6.67 units on a scale
Standard Deviation 24.0
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Social function 3 mo
|
-1.67 units on a scale
Standard Deviation 27.5
|
-1.67 units on a scale
Standard Deviation 27.5
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Social function 6 mo
|
6.67 units on a scale
Standard Deviation 27.5
|
-6.67 units on a scale
Standard Deviation 29.1
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Social function 12 mo
|
6.67 units on a scale
Standard Deviation 29.1
|
0.00 units on a scale
Standard Deviation 26.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical Health 3 mo
|
3.44 units on a scale
Standard Deviation 7.8
|
3.71 units on a scale
Standard Deviation 7.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical Health 6 mo
|
4.51 units on a scale
Standard Deviation 7.0
|
3.76 units on a scale
Standard Deviation 9.3
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Physical Health 12 mo
|
5.42 units on a scale
Standard Deviation 9.3
|
4.59 units on a scale
Standard Deviation 9.3
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 3 mo
|
-3.56 units on a scale
Standard Deviation 10.5
|
-1.99 units on a scale
Standard Deviation 8.9
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 6 mo
|
0.44 units on a scale
Standard Deviation 11.7
|
-1.09 units on a scale
Standard Deviation 7.0
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
SF-12_Changes from Basal - Mental Health 12 mo
|
-2.41 units on a scale
Standard Deviation 8.2
|
-1.56 units on a scale
Standard Deviation 9.1
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
VAS_Changes from Basal - 3 months
|
-13.67 units on a scale
Standard Deviation 30.7
|
-7.53 units on a scale
Standard Deviation 23.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
VAS_Changes from Basal - 6 months
|
-20.67 units on a scale
Standard Deviation 29.3
|
-11.93 units on a scale
Standard Deviation 20.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
VAS_Changes from Basal - 12 months
|
-21.20 units on a scale
Standard Deviation 28.5
|
-13.07 units on a scale
Standard Deviation 21.6
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
LEQUESNE_Changes from Basal - 3 months
|
-3.63 units on a scale
Standard Deviation 12.4
|
-5.18 units on a scale
Standard Deviation 12.8
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - General 3 months
|
-8.48 units on a scale
Standard Deviation 22.6
|
-4.52 units on a scale
Standard Deviation 17.4
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - General 12 months
|
-13.47 units on a scale
Standard Deviation 22.8
|
-4.10 units on a scale
Standard Deviation 18.4
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Dificulty 3 months
|
-8.51 units on a scale
Standard Deviation 22.8
|
-6.46 units on a scale
Standard Deviation 18.7
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Dificulty 6 months
|
-14.53 units on a scale
Standard Deviation 19.8
|
-6.97 units on a scale
Standard Deviation 20.5
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Dificulty 12 months
|
-12.59 units on a scale
Standard Deviation 23.1
|
-4.26 units on a scale
Standard Deviation 21.3
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
WOMAC11_Changes from Basal - Stiffness 12 months
|
-10.67 units on a scale
Standard Deviation 31.1
|
-4.50 units on a scale
Standard Deviation 29.5
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
LEQUESNE_Changes from Basal - 6 months
|
-13.95 units on a scale
Standard Deviation 10.8
|
-5.46 units on a scale
Standard Deviation 13.4
|
|
Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)
LEQUESNE_Changes from Basal - 12 months
|
-8.76 units on a scale
Standard Deviation 12.4
|
-3.13 units on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: up to one yearPopulation: The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.
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.
Outcome measures
| Measure |
Allogenic Mesenchymal Stromal Cells
n=12 Participants
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
n=15 Participants
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
|---|---|---|
|
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
MRI. Nº of values between 50-90 per visit. 0
|
12.33 number of values (range 0-88)
Standard Deviation 3.5
|
13.53 number of values (range 0-88)
Standard Deviation 5.7
|
|
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
MRI. Nº of values between 50-90 per visit. 6
|
9.33 number of values (range 0-88)
Standard Deviation 4.5
|
11.73 number of values (range 0-88)
Standard Deviation 7.5
|
|
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
MRI.Nº of values between 50-90 per visit.12.
|
8.25 number of values (range 0-88)
Standard Deviation 5.6
|
10.73 number of values (range 0-88)
Standard Deviation 5.5
|
|
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
MRI. Change of Nº of measurements. 6
|
-3.00 number of values (range 0-88)
Standard Deviation 2.5
|
-1.80 number of values (range 0-88)
Standard Deviation 5.8
|
|
Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)
MRI. Change of Nº of measurements.12
|
-4.08 number of values (range 0-88)
Standard Deviation 6.0
|
-2.80 number of values (range 0-88)
Standard Deviation 4.1
|
Adverse Events
Allogenic Mesenchymal Stromal Cells
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Hyaluronic Acid (Durolane)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Allogenic Mesenchymal Stromal Cells
n=15 participants at risk
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Injection of Mesenchymal Stromal Cells: 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
|
Hyaluronic Acid (Durolane)
n=15 participants at risk
Intraarticular injection of hyaluronic acid (60 mg)
Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Artralgia
|
40.0%
6/15 • Number of events 9 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
46.7%
7/15 • Number of events 9 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
13.3%
2/15 • Number of events 3 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
20.0%
3/15 • Number of events 4 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
13.3%
2/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Infections and infestations
Ear infection
|
20.0%
3/15 • Number of events 3 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
13.3%
2/15 • Number of events 3 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Infections and infestations
Nasofaringitis
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Infections and infestations
Rinitis
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Surgical and medical procedures
Dental implant
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
13.3%
2/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Reproductive system and breast disorders
Amenorrhea
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Reproductive system and breast disorders
Premature menopause
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Immune system disorders
Hypersensitivity
|
13.3%
2/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Nervous system disorders
Amnesia
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
13.3%
2/15 • Number of events 12 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Nervous system disorders
Drowsiness
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Gastrointestinal disorders
Dental pain
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
13.3%
2/15 • Number of events 2 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
General disorders
Leak
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Musculoskeletal and connective tissue disorders
Artralgia/Artritis
|
20.0%
3/15 • Number of events 3 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia/Effusion
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Eye disorders
Corneal erosion / Blepharitis
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
6.7%
1/15 • Number of events 1 • 1 year
All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
|
Additional Information
Professor Javier Garcia-Sancho
Instituto de Biología y Genética Molecular (IBGM)
Phone: 34 983 423 084
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor must review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER