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

Sponsor

Xijing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06109220

Collaborator

(none)

Enrollment

Location

Arm

21.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Behavioral: Stromal vascular fraction,SVF	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 SVF was injected into the knee cavity

Arm

Intervention/Treatment

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

SVF was injected into the knee cavity

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shannxi	China	710034

Sponsors and Collaborators

Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xijing Hospital

ClinicalTrials.gov Identifier:

NCT06109220

Other Study ID Numbers:

KY20232112-X-1

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xijing Hospital

Stromal vascular fraction

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 31, 2023