NCT05515523

Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)

Pilot Trial of Intra-articular Stromal Vascular Fraction for the Treatment of Knee Post-Trauma Osteoarthritis and Biomarker Identification

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).

Detailed description

Clinical treatment generally involves a life-long combination of exercise, lifestyle modifications, and/or analgesics. If pain becomes debilitating, different surgical options exist, including arthroscopic joint debridement and mechanical axis change through osteotomies around the knee and eventually joint replacement surgery for severe cases to improve the quality of life. However, patients under 40 years of age, who expect to continue an active lifestyle, have only a 40% "good or excellent" function score after total knee replacement, they are most likely to outlive their initial replacement and need revision.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
GENETIC	Adipose Derived (AD) Stromal Vascular Fraction (SVF)	autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain and function associated with OA of the knee joint

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-08-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study