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

NCT03166410 | Unknown

• 1 other identifier: SVFOA-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of Treatment-Emergent Adverse Events

  Subjects will be monitored for adverse events

  1 year

Secondary Outcomes (1)

• Efficacy - Change in Pain Scores at All Follow-up Visits

  3 months, 6 months, 1 year, 2 years

Study Arms (1)

Cell Treatment

EXPERIMENTAL

Procedure: Cell injection

Interventions

Cell injection PROCEDURE

Cell Treatment

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
• 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
• Subjects with ASA grade I, II, or III
• Males and females 25-85 years old
• Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months

You may not qualify if:

• Subjects that are allergic to lidocaine, epinephrine or valium
• 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
• Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
• Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
• Women that are pregnant or planning to become pregnant during the study
• Subjects on long term use of oral steroids
• History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site

Sponsors & Collaborators

• Texas Plastic Surgery: lead

Study Sites (1)

Texas Plastic Surgery

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Texas Plastic Surgery

CONTACT

info@txps.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)