NCT07259993

Knee Osteoarthritis With Stromal Vascular Fraction Cells

Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Michael H Carstens · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Later, subjects were followed for safety out and potential benefits.

Detailed description

A prospective, open-label interventional study was conducted to assess safety and evidence of clinical response to administration of intra-articular SVF in 16 patients with symptomatic, radiographic Kellgren Lawence grade 3 KOA. Approximately 55.5 million SVF cells were administered via intra-articular injection into each of the 29 knees; asymptomatic knees remained untreated. Subjects were followed for safety out to six months. Potential benefit was measured using the Knee Injury Osteoarthritis Outcome Scores (KOOS) at baseline (pre-treatment), at 3- and 6-months post-treatment, and then subsequently at 10 years.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	autologous adipose tissue-derived stromal vascular fraction cells	SVF cells via intra-articular injection into knees

Timeline

• Start date: 2013-08-27
• Primary completion: 2025-07-26
• Completion: 2025-10-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Nicaragua