Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity
Clinical Study on the Safety and Efficacy of Intrarticular Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) in the Treatment of Knee Osteoarthritis (KOA)
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Mar 2023
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedOctober 31, 2023
March 1, 2023
1.3 years
August 18, 2023
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
T2 mapping
The degree of change of articular cartilage was observed
24 months after the first SVF injection into the knee cavity
Secondary Outcomes (1)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
24 months after the first SVF injection into the knee cavity
Study Arms (1)
Stage of arthritis
EXPERIMENTALPatients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
Interventions
Eligibility Criteria
You may qualify if:
- The age range is 20-70 years old
- Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
- The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
- Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
- The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items
You may not qualify if:
- Patients with nonunion or displaced fractures around defective cartilage
- Pregnant or lactating women
- Autoimmune disease
- Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
- The patients had severe neurological diseases affecting the evaluation of postoperative results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shannxi, 710034, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
October 31, 2023
Study Start
March 30, 2023
Primary Completion
June 30, 2024
Study Completion
December 30, 2024
Last Updated
October 31, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share