NCT03513731

Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint

Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: InGeneron, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.

Detailed description

Patients will fall into two categories: treatment group (20 subjects) and non-treatment or control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive facet joint osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5 ml corticosteroid injection into the point of injury

Conditions

• Osteoarthritis of Facet Joint of Lumbar Spine

Interventions

Type	Name	Description
DEVICE	Adipose-derived stem cell injection	ADRC injection into the facet joint
DRUG	Corticosteroid injection	Corticosteroid injection into the facet joint

Timeline

• Start date: 2018-12-07
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2018-05-01
• Last updated: 2025-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study