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

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ClinicalTrials.gov Identifier: NCT02357485
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : March 27, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Plastic Surgery Education and Research Foundation
Information provided by (Responsible Party):
Peter B. Fodor MD, Fodor, Peter B, M.D.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Intervention Biological: ADSC
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm
Hide Arm/Group Description Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
Period Title: Overall Study
Started 6 [1]
Completed 6
Not Completed 0
[1]
6 subjects, 8 knees ( 2 bilateral & 4 unilateral)
Arm/Group Title Treatment Arm
Hide Arm/Group Description Single injection of ADSC
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Six (6) participants with eight (8) knees - Two (2) participants with bilateral OA (4 knees) Four (4) participant with unilateral OA (4 knees)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
59.3  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
1.Primary Outcome
Title Safety as Measured by Adverse Events
Hide Description Adverse Events were recorded during the entirety of the study.
Time Frame Entire Study (1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
All 6 participants were included in the analysis
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Single injection of ADSC
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Hide Description

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)

Time Frame Baseline to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Single injection of ADSC
Overall Number of Participants Analyzed 6
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 32.9  (14.6)
3 months Post-treatment 10.8  (13.1)
1 year Post-treatment 9.3  (11.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.004
Comments Baseline vs 1 year Post-treatment
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
Hide Description 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).
Time Frame Baseline to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Single injection of ADSC

ADSC: Single injection of ADSC

Overall Number of Participants Analyzed 6
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 5.9  (1.2)
3 months Post-treatment 1.8  (2.6)
1 year Post-treatment 2.0  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline vs 1 year Post-treatment
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
Hide Description 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.
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Single injection of ADSC
Overall Number of Participants Analyzed 6
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
8
Mean (Standard Deviation)
Unit of Measure: degrees
Pre-treatment 136.6  (7.3)
Post-treatment 143.6  (6.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Single injection of ADSC
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Pre-treatment 5.4  (1.6)
Post-treatment 2.8  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description Single injection of ADSC
All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Arm
Affected / at Risk (%)
Total   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Fodor, MD
Organization: UCLA Medical Center
Phone: 3102039818
Responsible Party: Peter B. Fodor MD, Fodor, Peter B, M.D.
ClinicalTrials.gov Identifier: NCT02357485     History of Changes
Other Study ID Numbers: OAKnee01
First Submitted: January 31, 2015
First Posted: February 6, 2015
Results First Submitted: February 13, 2015
Results First Posted: March 27, 2015
Last Update Posted: June 30, 2015