Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Study Overview
Brief Summary
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥ 35 years.
- •Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2~
- •Persistent knee pain after nonsurgical treatment.
Exclusion Criteria
- •Arthritis caused by other systemic or local immune diseases.
- •Patients who have undergone total knee replacement surgery.
- •Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
- •Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
- •Patients with severe heart problems and coagulation disorders.
- •Patients who have taken glucosamine within the previous month.
- •MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
Arms & Interventions
Stromal Vascular Fraction (SVF)
Ten patients with knee OA were administered intra-articular SVF injections.
Intervention: Intra-articular Stromal Vascular Fraction Injection (Procedure)
Outcomes
Primary Outcomes
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Baseline and at 3 and 6 months post-intervention
range from 0-96, with higher scores indicating greater OA-related disability
Magnetic resonance imaging (MRI)
Time Frame: Baseline and 6 months after the intervention
included T2 mapping
Visual Analogue Scale (VAS)
Time Frame: Baseline and at 3 and 6 months post-intervention
range from 0-10, with higher scores indicating increased degree of pain
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline and at 3 and 6 months post-intervention
5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA
Secondary Outcomes
No secondary outcomes reported
Investigators
Shu-Hao Chang, MD
Visiting staff
Fu Jen Catholic University Hospital