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

NCT06562101 | Completed

• 1 other identifier: FJUH109069
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  range from 0-96, with higher scores indicating greater OA-related disability

  Baseline and at 3 and 6 months post-intervention

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA

  Baseline and at 3 and 6 months post-intervention

• Visual Analogue Scale (VAS)

  range from 0-10, with higher scores indicating increased degree of pain

  Baseline and at 3 and 6 months post-intervention

• Magnetic resonance imaging (MRI)

  included T2 mapping

  Baseline and 6 months after the intervention

Study Arms (1)

Stromal Vascular Fraction (SVF)

EXPERIMENTAL

Ten patients with knee OA were administered intra-articular SVF injections.

Procedure: Intra-articular Stromal Vascular Fraction Injection

Interventions

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.

Also known as: Stromal Vascular Fraction therapy

Stromal Vascular Fraction (SVF)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shu-Hao Chang, MD: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

Location

Related Publications (15)

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• Anil U, Markus DH, Hurley ET, Manjunath AK, Alaia MJ, Campbell KA, Jazrawi LM, Strauss EJ. The efficacy of intra-articular injections in the treatment of knee osteoarthritis: A network meta-analysis of randomized controlled trials. Knee. 2021 Oct;32:173-182. doi: 10.1016/j.knee.2021.08.008. Epub 2021 Sep 6.

  PMID: 34500430 BACKGROUND

• Aletto C, Giordano L, Quaranta M, Zara A, Notarfrancesco D, Maffulli N. Short-term results of intra-articular injections of stromal vascular fraction for early knee osteoarthritis. J Orthop Surg Res. 2022 Jun 11;17(1):310. doi: 10.1186/s13018-022-03196-0.

  PMID: 35690837 BACKGROUND

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  PMID: 35118156 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shu-Hao Chang, MD

  Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Visiting staff

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: December 4, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

TW (1)