Knee Pain, Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, stem cell, knee pain, adipose derived stem cell, injection, MFAT, Micro Fragmented Adipose Tissue
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMicro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
BIOLOGICALCorticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 35 and 75 years-old * Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3. * Working understanding of the English language and able to fully understand the procedure * Capable of providing informed consent * Able to complete online, in-person or phone surveys for the purposes of follow-up * Capable of understanding pre- and post-procedure care instructions * Ambulatory at baseline * Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
Exclusion criteria
* Age \< 35 or \> 75 years old * Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 ) * Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc) * Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months * Co-morbidity with rheumatologic condition, inflammatory arthritis * Currently undergoing immunomodulatory therapy * Uncontrolled endocrine disorder * BMI \>35 * Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C \>7.0) * Pregnancy or planned pregnancy * previous stem cell injection into treatment joint * Patient scheduled to undergo any concomitant surgical procedures. * Coagulopathy or anticoagulant treatment * Chronic pain involving multiple body parts or opioid medication management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain | Baseline, 3, 6, 12, and 24 months | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). |
| Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms | Baseline, 3, 6, 12, and 24 months | Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm Score | Baseline, 3, 6, 12, and 24 months | Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score) |
| Veterans RAND 12 (VR-12) Score - Physical | Baseline, 3, 6, 12, and 24 months | 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). |
| Veterans RAND 12 (VR-12) Score - Mental | Baseline, 3, 6, 12, and 24 months | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREugene Y Roh, MD
Stanford University
PRINCIPAL_INVESTIGATORJason Dragoo, MD
Stanford University
PRINCIPAL_INVESTIGATORSeth Sherman, MD
Stanford University
Participant flow
Pre-assignment details
40 participants signed informed consent, 39 received randomized study injection and provided baseline information
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 10 |
| other Total, other adverse events | 0 / 30 | 0 / 10 |
| serious Total, serious adverse events | 0 / 30 | 0 / 10 |
Outcome results
None listed