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

• Sponsor: Texas Plastic Surgery (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03166410
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 53.9
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• 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: Jan 1, 2017
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety - Incidence of Treatment-Emergent Adverse Events [1 year]

   Subjects will be monitored for adverse events

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Plastic Surgery	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Texas Plastic Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime R. Garza, MD, Principal Investigator, Texas Plastic Surgery
• ClinicalTrials.gov Identifier: NCT03166410
• Other Study ID Numbers: SVFOA-01
• First Posted: May 25, 2017
• Last Update Posted: Mar 13, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Hip

Study Results

No Results Posted as of Mar 13, 2020