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Regenerative Medicine
Autologous adipose tissue knee injection for Osteoarthritis
N/A
Waitlist Available
Led By C.Thomas Vangsness, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in promis-29 from baseline to 6 months
Awards & highlights
Study Summary
This trial will compare the efficacy of a new "minimally manipulated" regenerative treatment (autologous fat) to the current standard of care (hyaluronic acid).
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in promis-29 from baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in promis-29 from baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
Secondary outcome measures
Clinical Anchors
Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)
Erythrocyte Indices
Other outcome measures
Force Plate Analysis
Short-term clinical evaluation - PROMIS
Short-term clinical evaluation - WOMAC
+1 moreSide effects data
From undefined Phase 3 trial • 332 Patients • NCT012403821%
Eye irritation
1%
Gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.1% HA
3% DE-089
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Autologous adipose tissue knee injectionExperimental Treatment1 Intervention
Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.
Group II: Hyaluronic Acid knee injectionActive Control1 Intervention
Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
909 Previous Clinical Trials
1,601,406 Total Patients Enrolled
3 Trials studying Osteoarthritis
18 Patients Enrolled for Osteoarthritis
C.Thomas Vangsness, MDPrincipal InvestigatorKeck School of Medicine of USC
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