Arthritis, Degenerative Clinical Trial
Official title:
Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee
Autologous adipose-derived stromal vascular fraction (SVF) was used to treat 10 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study. The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 3 ml of Lactated Ringer's Solution, with a mean of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell suspension was injected into the intra-articular space using ultrasound guidance. At 12 weeks post-op all 10 knees showed decreased pain and increased mobility, both statistically significant (α = .01). Nine of ten knees reported either maximum possible or very significant decrease in pain. No infections, acute pain flares, or other adverse events were reported. Patient ages ranged from 52 - 69 years with a mean of 59 years.
Status | Completed |
Enrollment | 6 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Study Subject voluntarily gives written Informed Consent to participate in the study and signs the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed. - The age range is from 20-70 years old. - Both female and male participants are eligible. - Females must be non-pregnant and those of child-bearing age will be pregnancy tested on-site at SMASA or RENEW on the day of, and prior to, surgery (Visit #2). - Participants will be in good health (ASA Class I-II) with a BMI < 35 - Failed a regimen of anti-inflammatory systemic medicines and/or physical therapy. - Knee pain graded as greater than 4 out of 10. - Mild to moderate arthritis as diagnosed by standard x-ray or MRI study. - Patients will be eligible for in-office surgical procedures at SMASA and RENEW. - Participants cannot be allergic to lidocaine, epinephrine, or valium. - Must speak, read and understand English. Exclusion Criteria: - Outside of the age range (20-70 years old). - BMI Index greater than 35. - Severe to end stage osteoarthritis,Grade IV, as diagnosed by plain x-ray or MRI study. - Hyaluronic acid gel injections to the affected knee joint within the last six months. - Corticosteroid injections to the affected knee joint within the past 3 months. - Current use of oral/systemic steroids. - History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection, uncontrolled diabetes mellitus, immunodeficiency disorders (HIV), lipoatrophy disorders (scleroderma, lupus etc.), rheumatoid arthritis or any other medical condition causing chronic or clinically significant pain. - Allergic to lidocaine, epinephrine, valium or sodium phosphate. - Individuals with diminished decision-making capacity will not be included in this research study. - All smokers and other tobacco users. - Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Renew Center, San Antonio, Texas |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | any adverse event related to procedure | 12 weeks | Yes |
Secondary | Validated PROMIS pain assessments | PROMIS validated pain assessment tools were used pre-op and at 12 weeks | 12 weeks | No |
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