Clinical trial NCT05019378: SVF Therapy for Human Knee Osteoarthritis
Official title: Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Cartilage Defect
Cartilage Regeneration
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

Detailed description: Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Knee Osteoarthritis
* Articular cartilage defect grades I/II of both knee

Exclusion Criteria:

* autoimmune or inflammatory arthritis
* serious medical disorders

Primary outcomes:
measure: Radiologic evaluation of knee articular cartilage Volume
timeFrame: Change from Baseline articular cartilage Volume at 12 weeks
measure: Radiologic evaluation of knee articular cartilage Volume
timeFrame: Change from Baseline articular cartilage Volume at 24 weeks
measure: Radiologic evaluation of knee articular cartilage Area
timeFrame: Change from Baseline articular cartilage Area at 12 weeks
measure: Radiologic evaluation of knee articular cartilage Area
timeFrame: Change from Baseline articular cartilage Area at 24 weeks
measure: Radiologic evaluation of knee articular cartilage Thickness
timeFrame: Change from Baseline articular cartilage Thickness at 12 weeks
measure: Radiologic evaluation of knee articular cartilage Thickness
timeFrame: Change from Baseline articular cartilage Thickness at 24 weeks
measure: Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
timeFrame: Change from Baseline WOMAC arthritis index score at 12 weeks.
measure: Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
timeFrame: Change from Baseline WOMAC arthritis index score at 24 weeks.
measure: Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
timeFrame: Change from Baseline Lysholm Knee Scale score at 12 weeks.
measure: Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
timeFrame: Change from Baseline Lysholm Knee Scale score at 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Xin Xiao Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan University
name: Lin Cai, MD
role: STUDY_DIRECTOR
References: