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

March 11, 2020 updated by: Jaime R. Garza, MD, Texas Plastic Surgery
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cell Treatment
Procedure: Cell injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 year
Subjects will be monitored for adverse events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVFOA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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