CClinicalTrials.gg
Status unknownNCT06109220Updated Oct 31, 2023

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

An interventional study of Stromal vascular fraction,SVF in Knee Osteoarthritis, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Stromal vascular fraction
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Stage of arthritis

    Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower

    Behavioral: Stromal vascular fraction,SVF

Interventions

  • BehavioralStromal vascular fraction,SVF

    SVF was injected into the knee cavity

06

What researchers measure

Primary outcomes

  1. T2 mapping

    The degree of change of articular cartilage was observed

    Time frame: 24 months after the first SVF injection into the knee cavity

Secondary outcomes

  1. 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.

    Time frame: 24 months after the first SVF injection into the knee cavity

07

Study locations

1 of 1 sites recruiting
  • Xijing Hospital
    Xi'an, Shannxi 710034, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06109220
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Oct 31, 2023
Start date
Mar 30, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Oct 31, 2023

Study contacts

Yanyan Jia
Contact
xiyyllwyh@163.com
+862984771794

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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