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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Procedure: Cell injection

• Registration Number: NCT03166410
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cell Treatment	Cell injection	-

Primary Outcome Measures

Name	Time	Method
Safety - Incidence of Treatment-Emergent Adverse Events	1 year	Subjects will be monitored for adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy - Change in Pain Scores at All Follow-up Visits	3 months, 6 months, 1 year, 2 years	Pain scores will be collected at all visits

Trial Locations

Locations (1)

Texas Plastic Surgery; 🇺🇸 San Antonio, Texas, United States