Trial Outcomes & Findings for ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint (NCT NCT02357485)

Results Overview

Adverse Events were recorded during the entirety of the study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

Entire Study (1 year)

Results posted on

2015-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=6 Participants Single injection of ADSC
Age, Continuous	59.3 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Entire Study (1 year)

Population: All 6 participants were included in the analysis

Adverse Events were recorded during the entirety of the study.

Outcome measures

Outcome measures
Measure	Treatment Arm n=6 Participants Single injection of ADSC
Safety as Measured by Adverse Events	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 1 year

Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment). WOMAC score: 0 (best) to 100 (worst)

Outcome measures

Outcome measures
Measure	Treatment Arm n=8 knees Single injection of ADSC
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pre-treatment	32.9 units on a scale Standard Deviation 14.6
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3 months Post-treatment	10.8 units on a scale Standard Deviation 13.1
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) 1 year Post-treatment	9.3 units on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline to 1 year

Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Treatment Arm n=8 knees Single injection of ADSC
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain Pre-treatment	5.9 units on a scale Standard Deviation 1.2
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain 3 months Post-treatment	1.8 units on a scale Standard Deviation 2.6
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain 1 year Post-treatment	2.0 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline to 3 months

Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.

Outcome measures

Outcome measures
Measure	Treatment Arm n=8 knees Single injection of ADSC
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion Pre-treatment	136.6 degrees Standard Deviation 7.3
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion Post-treatment	143.6 degrees Standard Deviation 6.7

SECONDARY outcome

Timeframe: baseline to 3 months

Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.

Outcome measures

Outcome measures
Measure	Treatment Arm n=6 Participants Single injection of ADSC
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). Pre-treatment	5.4 seconds Standard Deviation 1.6
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). Post-treatment	2.8 seconds Standard Deviation 0.3

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Fodor, MD

UCLA Medical Center

Phone: 3102039818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place