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Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee

NCT02276833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-10-28

No results posted yet for this study

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 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.

Conditions

  • Arthritis, Degenerative

Interventions

OTHER

intra-articular space injection of SVF

intra-articular injection of autologous adipose SVF derived in the same surgical procedure

Sponsors & Collaborators

  • Renew Center, San Antonio, Texas

    lead OTHER

Principal Investigators

  • Jaime R Garza, MD, DDS · Renew Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276833 on ClinicalTrials.gov