Back to resultsADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ADSC
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring ADSC, osteoarthritis, knee, adipose
Eligibility Criteria
Inclusion Criteria:
- voluntarily provided written Informed Consent
- ages 20-70
- male or female
- grades I-III radiologically documented OA of one or both knees
- American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
- knee pain graded as greater than 3 out of 10 on screening questionnaire
- able to speak, read and understand English -
Exclusion Criteria:
- patient parameters falling outside of the inclusion criteria
- current oral or parenteral steroid or blood thinner use
- hyaluronic acid-based injection to the affected knee joint within the previous six months
- corticosteroid injection to the affected knee joint within the previous three months
- end stage (Grade IV) OA
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Single injection of ADSC
Outcomes
Primary Outcome Measures
Safety as Measured by Adverse Events
Adverse Events were recorded during the entirety of the study.
Secondary Outcome Measures
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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)
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
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).
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
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.
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
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.
Full Information
NCT ID
NCT02357485
First Posted
January 31, 2015
Last Updated
June 26, 2015
Sponsor
Fodor, Peter B, M.D.
Collaborators
Plastic Surgery Education and Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02357485
Brief Title
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Official Title
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fodor, Peter B, M.D.
Collaborators
Plastic Surgery Education and Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
Detailed Description
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
ADSC, osteoarthritis, knee, adipose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Single injection of ADSC
Intervention Type
Biological
Intervention Name(s)
ADSC
Intervention Description
Single injection of ADSC
Primary Outcome Measure Information:
Title
Safety as Measured by Adverse Events
Description
Adverse Events were recorded during the entirety of the study.
Time Frame
Entire Study (1 year)
Secondary Outcome Measure Information:
Title
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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
Title
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
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
Title
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
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
Title
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
voluntarily provided written Informed Consent
ages 20-70
male or female
grades I-III radiologically documented OA of one or both knees
American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
knee pain graded as greater than 3 out of 10 on screening questionnaire
able to speak, read and understand English -
Exclusion Criteria:
patient parameters falling outside of the inclusion criteria
current oral or parenteral steroid or blood thinner use
hyaluronic acid-based injection to the affected knee joint within the previous six months
corticosteroid injection to the affected knee joint within the previous three months
end stage (Grade IV) OA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B Fodor, M.D.
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
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