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| Name | Class |
|---|---|
| Plastic Surgery Education and Research Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Single injection of ADSC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADSC | Biological | Single injection of ADSC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Measured by Adverse Events | Adverse Events were recorded during the entirety of the study. | Entire Study (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter B Fodor, M.D. | Private Practice | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Six (6) participants with eight (8) knees - Two (2) participants with bilateral OA (4 knees) Four (4) participant with unilateral OA (4 knees)
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Single injection of ADSC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety as Measured by Adverse Events | Adverse Events were recorded during the entirety of the study. | All 6 participants were included in the analysis | Posted | Number | percentage of participants | Entire Study (1 year) |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Single injection of ADSC |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Fodor, MD | UCLA Medical Center | 3102039818 | pbfodor@centurysurgery.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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). |
| Baseline to 1 year |
| 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. | Baseline to 3 months |
| 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. | baseline to 3 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year | knees | Participants |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year | knees | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | degrees | Baseline to 3 months | knees | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | baseline to 3 months |
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| 0 |
| 6 |
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| 6 |
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| Title | Measurements |
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| Title | Measurements |
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