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NCT Number: NCT06562101

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-articular Stromal Vascular Fraction Injection

Procedure

Adipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions.

Other names: Stromal Vascular Fraction therapy

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Magnetic resonance imaging (MRI)

    Time frame: Baseline and 6 months after the intervention

    included T2 mapping

Sponsors and collaborators

Lead sponsor

Shu-Hao Chang, MD

Other

Registry information

Official study title

Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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