Osteoarthritis
Conditions
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.
Interventions
PROCEDURECell injection
Sponsors
Texas Plastic Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Incidence of Treatment-Emergent Adverse Events | 1 year | Subjects will be monitored for adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactTexas Plastic Surgery
Outcome results
None listed