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

NCT ID: NCT03166410

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-07-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cell Treatment

Group Type: EXPERIMENTAL

Cell injection

Intervention Type: PROCEDURE

Interventions

Cell injection

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Plastic Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Jaime R. Garza, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Texas Plastic Surgery

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Texas Plastic Surgery

Role: CONTACT

info@txps.net

Other Identifiers

SVFOA-01

Identifier Type: -

Identifier Source: org_study_id