SVF Therapy for Human Knee Osteoarthritis

August 24, 2021 updated by: Zhongnan Hospital

Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis

The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Study Type

Interventional

Enrollment (Actual)

6

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 437200
        • Zhongnan Hospital of Wuhan University

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Knee Osteoarthritis
  • Articular cartilage defect grades I/II of both knee

Exclusion Criteria:

  • autoimmune or inflammatory arthritis
  • serious medical disorders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous SVF treatment
Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint
Procedure: SVF treatment
autologous SVF (10E8 cells)
No Intervention: Placebo group
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologic evaluation of knee articular cartilage Volume
Time Frame: Change from Baseline articular cartilage Volume at 12 weeks
The Volume (cubic millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Volume at 12 weeks
Radiologic evaluation of knee articular cartilage Volume
Time Frame: Change from Baseline articular cartilage Volume at 24 weeks
The Volume (cubic millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Volume at 24 weeks
Radiologic evaluation of knee articular cartilage Area
Time Frame: Change from Baseline articular cartilage Area at 12 weeks
The Area (square millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Area at 12 weeks
Radiologic evaluation of knee articular cartilage Area
Time Frame: Change from Baseline articular cartilage Area at 24 weeks
The Area (square millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Area at 24 weeks
Radiologic evaluation of knee articular cartilage Thickness
Time Frame: Change from Baseline articular cartilage Thickness at 12 weeks
The Thickness (millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Thickness at 12 weeks
Radiologic evaluation of knee articular cartilage Thickness
Time Frame: Change from Baseline articular cartilage Thickness at 24 weeks
The Thickness (millimeter) of knee articular cartilage are measured.
Change from Baseline articular cartilage Thickness at 24 weeks
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Time Frame: Change from Baseline WOMAC arthritis index score at 12 weeks.
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Change from Baseline WOMAC arthritis index score at 12 weeks.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Time Frame: Change from Baseline WOMAC arthritis index score at 24 weeks.
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Change from Baseline WOMAC arthritis index score at 24 weeks.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
Time Frame: Change from Baseline Lysholm Knee Scale score at 12 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Change from Baseline Lysholm Knee Scale score at 12 weeks.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
Time Frame: Change from Baseline Lysholm Knee Scale score at 24 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Change from Baseline Lysholm Knee Scale score at 24 weeks.

Collaborators and Investigators

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

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Xin Xiao Zheng, MD, Wuhan University
  • Study Director: Lin Cai, MD, Wuhan University

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 19, 2016

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhongnanzxx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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