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

Knee Osteoarthritis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109220
• Other study ID #: KY20232112-X-1
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: Xijing Hospital
• Contact: Yanyan Jia
• Phone: +862984771794
• Email: xiyyllwyh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 ?, ? and ?
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Stromal vascular fraction,SVF
SVF was injected into the knee cavity

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T2 mapping	The degree of change of articular cartilage was observed	24 months after the first SVF injection into the knee cavity
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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.	24 months after the first SVF injection into the knee cavity