Status:
COMPLETED
Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee
Lead Sponsor:
Renew Center, San Antonio, Texas
Conditions:
Arthritis, Degenerative
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
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 a...
Detailed Description
Methods: Adipose Harvest. Using no oral or parenteral sedation, standard wetting solution (1 liter Lactated Ringer's, 50 milligrams of 1% lidocaine, and 1 cc of 1:1000 epinephrine) was infused throug...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02276833
Start Date
April 1 2013
End Date
July 1 2013
Last Update
October 28 2014
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