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This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MFAT(Micro Fragmented Adipose Tissue) | Experimental | Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's knee. Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection |
|
| Conventional therapy | Active Comparator | Intra-articular injection of corticosteroid (Triamcinolone 40mg). Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro Fragmented Adipose Tissue | Biological | Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). | Baseline, 3, 6, 12, and 24 months |
| Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). | Baseline, 3, 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm Score | Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score) | Baseline, 3, 6, 12, and 24 months |
| Veterans RAND 12 (VR-12) Score - Physical | Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD). |
| Measure | Description | Time Frame |
|---|---|---|
| MRI Cartilage Scan | Cartilage thickness on MRI using T2-weighted cartilage mapping | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Y Roh, MD | Stanford University | Principal Investigator |
| Jason Dragoo, MD | Stanford University | Principal Investigator |
| Seth Sherman, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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40 participants signed informed consent, 39 received randomized study injection and provided baseline information
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| ID | Title | Description |
|---|---|---|
| FG000 | MFAT(Micro Fragmented Adipose Tissue) | Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. |
| FG001 | Conventional Therapy | Intra-articular injection of corticosteroid (Triamcinolone 40mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who started study procedures
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| ID | Title | Description |
|---|---|---|
| BG000 | MFAT(Micro Fragmented Adipose Tissue) | Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. |
| BG001 | Conventional Therapy |
| 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 | Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). | Participants with data at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 12, and 24 months |
|
Up to 2 years
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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 | MFAT(Micro Fragmented Adipose Tissue) | Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's knee. Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Cooridnator | Stanford Unviersity | 6507230003 | jessn16@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2020 | Sep 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2025 | Oct 24, 2025 | SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
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| Corticosteroid injection | Biological | Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. |
|
| Baseline, 3, 6, 12, and 24 months |
| Veterans RAND 12 (VR-12) Score - Mental | Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD). | Baseline, 3, 6, 12, and 24 months |
Intra-articular injection of corticosteroid (Triamcinolone 40mg). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | All Participants | Combined analysis of all participants. |
|
|
|
| Primary | Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). | Participants with data at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 12, and 24 months |
|
|
|
|
| Secondary | Lysholm Score | Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score) | Participants with data at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 12, and 24 months |
|
|
|
|
| Secondary | Veterans RAND 12 (VR-12) Score - Physical | Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD). | Participants with data at the respective time point. | Posted | Mean | Standard Deviation | T-score | Baseline, 3, 6, 12, and 24 months |
|
|
|
|
| Secondary | Veterans RAND 12 (VR-12) Score - Mental | Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD). | Participants with data at the respective time point. | Posted | Mean | Standard Deviation | T-score | Baseline, 3, 6, 12, and 24 months |
|
|
|
|
| Other Pre-specified | MRI Cartilage Scan | Cartilage thickness on MRI using T2-weighted cartilage mapping | Not Posted | 12 months | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Conventional Therapy | Intra-articular injection of corticosteroid (Triamcinolone 40mg). Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Change at 3 Months |
|
|
| Change at 6 Months |
|
|
| Change at 12 Months |
|
|
| Change at 24 Months |
|
|
| two-sample t-test |
| 0.839 |
The a priori threshold for statistical significance was < 0.05. |
| Other |
| Between-group analysis of change at 12 months | two-sample t-test | 0.791 | The a priori threshold for statistical significance was < 0.05. | Other |
| Between-group analysis of change at 24 months | two-sample t-test | 0.241 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 3 | paired t-test | 0.149 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 6 months | paired t-test | 0.006 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 12 months | paired t-test | 0.008 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 24 months | paired t-test | 0.002 | The a priori threshold for statistical significance was < 0.05. | Other |
| Change at 3 Months |
|
|
| Change at 6 Months |
|
|
| Change at 12 Months |
|
|
| Change at 24 Months |
|
|
| two-sample t-test |
| 0.158 |
The a priori threshold for statistical significance was < 0.05. |
| Other |
| Between-group analysis of change at 12 months | two-sample t-test | 0.358 | The a priori threshold for statistical significance was < 0.05. | Other |
| Between-group analysis of change at 24 months | two-sample t-test | 0.996 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 3 months | paired t-test | 0.004 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 6 months | paired t-test | 0.001 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 12 months | paired t-test | 0.002 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at 24 months | paired t-test | 0.019 | The a priori threshold for statistical significance was < 0.05. | Other |
| Change at 3 Months |
|
|
| Change at 6 Months |
|
|
| Change at 12 Months |
|
|
| Change at 24 Months |
|
|
| two-sample t-test |
| 0.820 |
The a priori threshold for statistical significance was < 0.05. |
| Other |
| Between-group analysis of change at 12 months | two-sample t-test | 0.867 | The a priori threshold for statistical significance was < 0.05. | Other |
| Between-group analysis of change at 24 months | two-sample t-test | 0.439 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 3 | paired t-test | 0.004 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 6 | paired t-test | 0.003 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 12 | paired t-test | <0.001 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 24 | paired t-test | 0.008 | The a priori threshold for statistical significance was < 0.05. | Other |
| Change at 3 Months |
|
|
| Change at 6 Months |
|
|
| Change at 12 Months |
|
|
| Change at 24 Months |
|
|
| two-sample t-test |
| 0.686 |
The a priori threshold for statistical significance was < 0.05. |
| Other |
| Between-group analysis of change at 12 months | two-sample t-test | 0.229 | The a priori threshold for statistical significance was < 0.05. | Other |
| Between-group analysis of change at 24 months | two-sample t-test | 0.564 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 3 | paired t-test | 0.122 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 6 | paired t-test | 0.027 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 12 | paired t-test | 0.018 | The a priori threshold for statistical significance was < 0.05. | Other |
| Analysis of change at month 24 | paired t-test | 0.232 | The a priori threshold for statistical significance was < 0.05. | Other |