Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GID | Osteoarthritis, Knee | United States
Previous Study | Return to List | Next Study

Adipose-derived SVF for the Treatment of Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726945
Recruitment Status : Completed
First Posted : April 4, 2016
Results First Posted : August 21, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
The GID Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis (OA)
Interventions Device: GID SVF-2
Other: Placebo
Enrollment 39
Recruitment Details Recruitment opened April 2015 and the first subject was enrolled in the study in July 2016. Recruitment was completed in September 2017.
Pre-assignment Details  
Arm/Group Title Low Dose SVF High Dose SVF Placebo
Hide Arm/Group Description This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA. This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA. This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
Period Title: Overall Study
Started 13 13 13
Completed 13 12 12
Not Completed 0 1 1
Reason Not Completed
Withdrawal by Subject             0             0             1
Elected to have total knee replacement             0             1             0
Arm/Group Title Low Dose SVF High Dose SVF Placebo Total
Hide Arm/Group Description This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA. This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA. This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA. Total of all reporting groups
Overall Number of Baseline Participants 13 13 13 39
Hide Baseline Analysis Population Description
All subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 13 participants 39 participants
60.5  (7.9) 59.5  (11.7) 57.1  (9.1) 59.0  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
Female
9
  69.2%
6
  46.2%
7
  53.8%
22
  56.4%
Male
4
  30.8%
7
  53.8%
6
  46.2%
17
  43.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
Hispanic or Latino
1
   7.7%
2
  15.4%
3
  23.1%
6
  15.4%
Not Hispanic or Latino
12
  92.3%
11
  84.6%
10
  76.9%
33
  84.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   7.7%
1
   2.6%
White
13
 100.0%
13
 100.0%
12
  92.3%
38
  97.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 13 participants 39 participants
13 13 13 39
Kellgren Lawrence Osteoarthritis Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
KL Grade II
4
  30.8%
4
  30.8%
4
  30.8%
12
  30.8%
KL Grade III
9
  69.2%
9
  69.2%
9
  69.2%
27
  69.2%
[1]
Measure Description:

Kellgren-Lawrence Osteoarthritis Scale

  • Grade 0, None – No radiographic features of OA are present
  • Grade 1, Doubtful – Doubtful narrowing of joint space and possible osteophytic lipping
  • Grade 2, Minimal – Definite osteophytes and possible narrowing of joint space on anteroposterior weight-bearing radiograph
  • Grade 3, Moderate – Moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
  • Grade 4, Severe – Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
1.Primary Outcome
Title Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
Hide Description Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty-eight subjects were monitored to 1 year. One subject was monitored for 6 weeks, when the subject withdrew from the study to receive a total knee replacement.
Arm/Group Title Low Dose SVF High Dose SVF Placebo
Hide Arm/Group Description:
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
Overall Number of Participants Analyzed 13 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
Device Related Serious Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
MRI abnormalities
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months
Hide Description

The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable.

The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.

Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data set was analyzed with an Intent-to-treat principle and used the last observation carried forward (LOCF) method for missing data.
Arm/Group Title Low Dose SVF High Dose SVF Placebo
Hide Arm/Group Description:
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
Overall Number of Participants Analyzed 13 13 13
Median (Inter-Quartile Range)
Unit of Measure: percentage of change in WOMAC score
52
(29 to 88)
84
(19 to 91)
25
(-25 to 58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose SVF, Placebo
Comments

Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .

Statistical significance was defined as either of the treatment groups to be superior to the placebo group.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Dose SVF, Placebo
Comments

Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .

Statistical significance was defined as either of the treatment groups to be superior to the placebo group.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose SVF High Dose SVF Placebo
Hide Arm/Group Description This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA. This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA. This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
All-Cause Mortality
Low Dose SVF High Dose SVF Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/13 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
Low Dose SVF High Dose SVF Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose SVF High Dose SVF Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      2/13 (15.38%)      0/13 (0.00%)    
Infections and infestations       
Possible Infection  [1]  1/13 (7.69%)  1 1/13 (7.69%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Swelling  [2]  0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Sterility test showed 1 suspicious colony at 3 days. The patients showed no sign of infection.
[2]
Swelling of the knee that resolved spontaneously
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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Affairs
Organization: The GID Group
Phone: 7204124233
EMail: vgood@thegidgroup.com
Publications:
Garza GR, Palomera T, Dumanian GA and Dos-Anjos S. Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Feasibility and Safety study. J Regen Med. 2015;4(1)
Layout table for additonal information
Responsible Party: The GID Group
ClinicalTrials.gov Identifier: NCT02726945    
Other Study ID Numbers: GIDOA-01
First Submitted: March 24, 2016
First Posted: April 4, 2016
Results First Submitted: May 29, 2019
Results First Posted: August 21, 2019
Last Update Posted: March 2, 2020