NCT03503305

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells

• Status: Active Not 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, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.

Detailed description

The focus of this study is to investigate the therapeutic benefit of autologous adipose-derived regenerative cells in patients with wrist arthritis. The hypothesis of this trial is that the use of adult-adipose derived regenerative cells as a treatment of wrist arthritis will induce healing and decrease pain compared to the control group. With adult-adipose derived regenerative cell administration, the medical practitioner would anticipate a reduction in inflammation, acceleration in healing, decreased pain in patients post procedure, and increased function and strength in the affected wrist. Currently, no clinical studies have been constructed to determine the efficacy of ADRCs in wrist arthritis patients. Subjects will fall into two categories: treatment group (20) and control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive wrist osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the wrist. The control group will receive a 5 ml cortisone injection into the wrist.

Conditions

• Osteoarthritis of the Wrist

Interventions

Type	Name	Description
DEVICE	adipose-derived stem cell injection	5 ml injection of adipose derived stem cells
DRUG	Corticosteroid injection	5 ml injection of corticosteroid

Timeline

• Start date: 2018-11-21
• Primary completion: 2026-03-01
• Completion: 2026-08-01
• First posted: 2018-04-19
• Last updated: 2025-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study