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

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ClinicalTrials.gov Identifier: NCT02276833
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Jaime R. Garza, MD, DDS, Renew Center, San Antonio, Texas

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 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.

Condition or disease Intervention/treatment Phase
Arthritis, Degenerative Other: intra-articular space injection of SVF Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Single patient group with qualifying OA
intra-articular space injection of SVF Single patient group with pre-operative and post-operative assessments
Other: intra-articular space injection of SVF
intra-articular injection of autologous adipose SVF derived in the same surgical procedure




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks ]
    any adverse event related to procedure


Secondary Outcome Measures :
  1. Validated PROMIS pain assessments [ Time Frame: 12 weeks ]
    PROMIS validated pain assessment tools were used pre-op and at 12 weeks



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276833


Sponsors and Collaborators
Renew Center, San Antonio, Texas
Investigators
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Principal Investigator: Jaime R Garza, MD, DDS Renew Center

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Responsible Party: Jaime R. Garza, MD, DDS, Jaime R. Garza, M.D., Renew Center, San Antonio, Texas
ClinicalTrials.gov Identifier: NCT02276833     History of Changes
Other Study ID Numbers: OA-001
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases