Trial Outcomes & Findings for Treatment of Tendon Injury Using Mesenchymal Stem Cells (NCT NCT01856140)

Results Overview

Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 6 weeks, 12 weeks after intervention

Results posted on

2022-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	1 Million Cells/ml of ALLO-ASC 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Tendon Injury Using Mesenchymal Stem Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Million Cells/ml of ALLO-ASC n=6 Participants 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 Participants 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	50.5 years STANDARD_DEVIATION 11.1 • n=7 Participants	51.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment South Korea	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks after intervention

Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.

Outcome measures

Outcome measures
Measure	1 Million Cells/ml of ALLO-ASC n=6 Participants 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 Participants 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks Baseline	3.57 score on a scale Standard Deviation 2.1	3.02 score on a scale Standard Deviation 1.34
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks Post-injection 6 weeks	2.93 score on a scale Standard Deviation 3.06	1.60 score on a scale Standard Deviation 1.80
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks Post-injection 12 weeks	1.68 score on a scale Standard Deviation 1.90	0.87 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks after the intervention

The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function.

Outcome measures

Outcome measures
Measure	1 Million Cells/ml of ALLO-ASC n=6 Participants 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 Participants 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Modified Mayo Clinic Performance Index for the Elbow Post-injection 6 weeks	83.75 score on a scale Standard Deviation 14.90	90.41 score on a scale Standard Deviation 6.97
Modified Mayo Clinic Performance Index for the Elbow Baseline	57.92 score on a scale Standard Deviation 15.03	70.00 score on a scale Standard Deviation 9.22
Modified Mayo Clinic Performance Index for the Elbow Post-injection 12 weeks	87.92 score on a scale Standard Deviation 9.41	91.67 score on a scale Standard Deviation 1.44

SECONDARY outcome

Timeframe: Baseline, 6 weeks, and 12 weeks after the intervention

Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.

Outcome measures

Outcome measures
Measure	1 Million Cells/ml of ALLO-ASC n=6 Participants 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 Participants 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Defect Area of Tendon by Ultrasonography in Long Axis Baseline	4197 mm^2 Standard Deviation 2607	5246 mm^2 Standard Deviation 2159
Defect Area of Tendon by Ultrasonography in Long Axis Post-injection 6weeks	4163 mm^2 Standard Deviation 1751	4383 mm^2 Standard Deviation 1558
Defect Area of Tendon by Ultrasonography in Long Axis Post-injection 12 weeks	2381 mm^2 Standard Deviation 1342	2516 mm^2 Standard Deviation 1989

SECONDARY outcome

Timeframe: Baseline, 6 weeks, and 12 weeks after the intervention

Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area. With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times. Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.

Outcome measures

Outcome measures
Measure	1 Million Cells/ml of ALLO-ASC n=6 Participants 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 Participants 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Defect Area of Tendon by Ultrasonography in Short Axis Baseline	3726 mm^2 Standard Deviation 2341	5018 mm^2 Standard Deviation 2494
Defect Area of Tendon by Ultrasonography in Short Axis Post-injection 6 weeks	3797 mm^2 Standard Deviation 1753	2849 mm^2 Standard Deviation 1601
Defect Area of Tendon by Ultrasonography in Short Axis Post-injection 12 weeks	2703 mm^2 Standard Deviation 1418	2223 mm^2 Standard Deviation 599

Adverse Events

1 Million Cells/ml of ALLO-ASC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

10 Million Cells/ml of ALLO-ASC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1 Million Cells/ml of ALLO-ASC n=6 participants at risk 1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	10 Million Cells/ml of ALLO-ASC n=6 participants at risk 10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Musculoskeletal and connective tissue disorders Swelling at injection site	50.0% 3/6 • Number of events 3 • 52 weeks	50.0% 3/6 • Number of events 3 • 52 weeks

Additional Information

Dr. Sang Yoon Lee

Seoul National University College of Medicine

Phone: 028702673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place