Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: Stromal vascular fraction,SVF

• Registration Number: NCT06109220
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-30
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stage of arthritis	Stromal vascular fraction,SVF	Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower

Primary Outcome Measures

Name	Time	Method
T2 mapping	24 months after the first SVF injection into the knee cavity	The degree of change of articular cartilage was observed

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	24 months after the first SVF injection into the knee cavity	The WOMAC is a specific assessment scale for osteoarthritis, which is assessed according to three aspects: pain, stiffness and function. A total of 24 WOMAC scores were scored, 0-10 points for each item, with a total score of 240 points. A total score \<80 was mild OA, a total score of 80-120 was moderate OA, and a total score of \>120 was severe OA.The severity and therapeutic effect of arthritis were evaluated according to the relevant symptoms and signs of patients.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China