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

August 19, 2024 updated by: Shu-Hao Chang, MD

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stromal Vascular Fraction (SVF)
Ten patients with knee OA were administered intra-articular SVF injections.
Procedure: Intra-articular Stromal Vascular Fraction Injection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and at 3 and 6 months post-intervention
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
Baseline and at 3 and 6 months post-intervention
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
Baseline and at 3 and 6 months post-intervention
Magnetic resonance imaging (MRI)
Time Frame: Baseline and 6 months after the intervention
included T2 mapping
Baseline and 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shu-Hao Chang, MD

Investigators

  • Principal Investigator: Shu-Hao Chang, MD, Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH109069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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