Clinical trial NCT06562101: Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees
Official title: Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline and at 3 and 6 months post-intervention
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline and at 3 and 6 months post-intervention
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline and at 3 and 6 months post-intervention
measure: Magnetic resonance imaging (MRI)
timeFrame: Baseline and 6 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital
Study officials:
affiliation: Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University
name: Shu-Hao Chang, MD
role: PRINCIPAL_INVESTIGATOR
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