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Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints

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ClinicalTrials.gov Identifier: NCT03166410
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jaime R. Garza, MD, Texas Plastic Surgery

Brief Summary:
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Cell injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 Hip, Knee, Ankle, and Thumb Joints
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Cell Treatment Procedure: Cell injection



Primary Outcome Measures :
  1. Safety - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    Subjects will be monitored for adverse events


Secondary Outcome Measures :
  1. Efficacy - Change in Pain Scores at All Follow-up Visits [ Time Frame: 3 months, 6 months, 1 year, 2 years ]
    Pain scores will be collected at all visits



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
  2. Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
  3. Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
  4. Subjects with ASA grade I, II, or III
  5. Males and females 25-85 years old
  6. Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months

Exclusion Criteria:

  1. Subjects that are allergic to lidocaine, epinephrine or valium
  2. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
  3. Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
  4. Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
  5. Women that are pregnant or planning to become pregnant during the study
  6. Subjects on long term use of oral steroids
  7. History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site

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): NCT03166410


Contacts
Contact: Texas Plastic Surgery info@txps.net

Locations
United States, Texas
Texas Plastic Surgery Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Texas Plastic Surgery

Responsible Party: Jaime R. Garza, MD, Principal Investigator, Texas Plastic Surgery
ClinicalTrials.gov Identifier: NCT03166410     History of Changes
Other Study ID Numbers: SVFOA-01
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

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