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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
5 ml injection of adipose derived stem cells
5 ml injection of corticosteroid
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
HD Research
Houston, Texas, United States
Safety - Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Time frame: 12 months
Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits
Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)
Time frame: 3, 6 and 12 months
Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits
Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)
Time frame: 3, 6 and 12 months
Efficacy - Change in Function Scores on the QuickDASH at All Follow-up
Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)
Time frame: 3, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.