SVF Therapy for Human Knee Osteoarthritis

NCT05019378 | Completed DMC

• 1 other identifier: Zhongnanzxx
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Cartilage Defect; Cartilage Regeneration

Outcome Measures

Primary Outcomes (10)

• Radiologic evaluation of knee articular cartilage Volume

  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

  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

  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

  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

  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

  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])

  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])

  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)

  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)

  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.

Study Arms (2)

autologous SVF treatment

EXPERIMENTAL

Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint

Procedure: SVF treatment

Placebo group

NO INTERVENTION

No treatment

Interventions

SVF treatment PROCEDURE

autologous SVF (10E8 cells)

autologous SVF treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• autoimmune or inflammatory arthritis
• serious medical disorders

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 437200, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Xin Xiao Zheng, MD

  Wuhan University

  PRINCIPAL INVESTIGATOR

• Lin Cai, MD

  Wuhan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 24, 2021
• Study Start: December 19, 2016
• Primary Completion: August 23, 2018
• Study Completion: January 28, 2019
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: starting 6 months after publication

Locations

CN (1)