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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166410
• Other study ID #: SVFOA-01
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Texas Plastic Surgery
• Contact: Texas Plastic Surgery
• Email: info[@]txps.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Cell injection

Locations

Country	Name	City	State
United States	Texas Plastic Surgery	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Plastic Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Incidence of Treatment-Emergent Adverse Events	Subjects will be monitored for adverse events	1 year
Secondary	Efficacy - Change in Pain Scores at All Follow-up Visits	Pain scores will be collected at all visits	3 months, 6 months, 1 year, 2 years