Osteoarthritis of the Knee
Conditions
Keywords
ADSC, osteoarthritis, knee, adipose
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.
Interventions
BIOLOGICALADSC
Single injection of ADSC
Sponsors
Plastic Surgery Education and Research Foundation
Fodor, Peter B, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Measured by Adverse Events | Entire Study (1 year) | Adverse Events were recorded during the entirety of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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) |
| Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain | 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). |
| Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion | 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. |
| Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Single injection of ADSC | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Safety as Measured by Adverse Events
Adverse Events were recorded during the entirety of the study.
Time frame: Entire Study (1 year)
Population: All 6 participants were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Safety as Measured by Adverse Events | 0 percentage of participants |
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.
Time frame: Baseline to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion | Pre-treatment | 136.6 degrees | Standard Deviation 7.3 |
| Treatment Arm | Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion | Post-treatment | 143.6 degrees | Standard Deviation 6.7 |
p-value: 0.053t-test, 2 sided
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).
Time frame: Baseline to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | 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 |
| Treatment Arm | 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 |
| Treatment Arm | 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 |
p-value: <0.001t-test, 2 sided
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)
Time frame: Baseline to 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | 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 |
| Treatment Arm | 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 |
| Treatment Arm | 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 |
p-value: <0.004t-test, 2 sided
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.
Time frame: baseline to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). | Post-treatment | 2.8 seconds | Standard Deviation 0.3 |
| Treatment Arm | Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). | Pre-treatment | 5.4 seconds | Standard Deviation 1.6 |
p-value: 0.003t-test, 2 sided