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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06109220
Enrollment
30
Registered
2023-10-31
Start date
2023-03-30
Completion date
2024-12-30
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Stromal vascular fraction

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.

Interventions

BEHAVIORALStromal vascular fraction,SVF

SVF was injected into the knee cavity

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
T2 mapping24 months after the first SVF injection into the knee cavityThe degree of change of articular cartilage was observed

Secondary

MeasureTime frameDescription
Western Ontario and McMaster Universities Arthritis Index (WOMAC)24 months after the first SVF injection into the knee cavityThe 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.

Countries

China

Contacts

Primary ContactYanyan Jia
xiyyllwyh@163.com+862984771794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026