Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Intra-articular Stromal Vascular Fraction Injection

• Registration Number: NCT06562101
• Lead Sponsor: Shu-Hao Chang, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Aged ≥ 35 years.
• Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2~4.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stromal Vascular Fraction (SVF)	Intra-articular Stromal Vascular Fraction Injection	Ten patients with knee OA were administered intra-articular SVF injections.

Primary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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)	Baseline and 6 months after the intervention	included T2 mapping
Visual Analogue Scale (VAS)	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)	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

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital; 🇨🇳 New Taipei City, Taiwan