Clinical Use in the USA

The Celution System is for investigational use only in the United States. Over 200 patients have been enrolled in completed Cytori-sponsored clinical trials conducted in the USA under FDA oversight as part of investigational use.

IndicationTrialDesignNumber of PatientsNumber of SitesResults
Heart FailureATHENA*Randomized (1:1), placebo-controlled, double-blind309Improvement in health-related quality of life
Osteoarthritis of the kneeACT-OARandomized (2:1), placebo-controlled, double-blind9412Trends favored treatment arm in pain and use of pain medication and in MRI of the joint
Hand Function in the autoimmune disease sclerodermaSTARRandomized (1:1), placebo-controlled, double-blind8819Clinically-meaningful improvement in hand function and reduced disability in patients with diffuse cutaneous SSc

*Results from the ATHENA study have been published (Henry et al (2017) Catheter Cardiovasc Interv. 1;89(2):169-177

In addition to the RELIEF Trial, there is also an ongoing FDA-approved clinical trial using the Celution System and ADRCs in patients with osteonecrosis of the hip.

Clinical Use Outside the USA

The Celution System is CE Marked as a medical device in Europe. Clinical use outside of approved clinical trials is subject to local, national, and regional regulatory requirements.

Ongoing Clinical Studies Outside of the USA

Stress Urinary Incontinence Following Prostatectom

Stress urinary incontinence (SUI) is a common side effect of prostate surgery. Men with this problem have difficulty controlling urine flow when they sneeze, laugh, or engage in many other kinds of everyday activity. ADRESU is a multi-center 45 patient clinical trial of ADRCs for male urinary incontinence following radical prostatectomy being conducted in Japan

The ADRESU trial was based on a promising pilot trial with short-term data of 11 patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found in the journal BMC Urology, on clinicaltrials.gov, and on the University Hospital Medical Information Network website.

Primary funding and support of the ADRESU trial is provided by the Japanese Ministry of Health, Labor and Welfare and Nagoya University.

Hand Function in Systemic Sclerosis

The SCLERADEC-II clinical trial has enrolled 40 patients at 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris. The primary endpoint is improvement over baseline in the Cochin Hand Function Scale at 3 months. Full analysis of the unblinded data set, including results for secondary endpoints such as pain, quality of life, mobility, strength, tactile sensitivity, Raynaud’s Phenomenon, and vascular suppression, will be performed upon completion of the final patient’s 6 month follow-up visit. Data will be available in the second half of 2018. SCLERADEC-II builds on a successful open label Phase I trial of ADRCs in this patient population. SCLERADEC-I reported improved hand function, reduced disability, and reduction in Raynaud’s Phenomenon.

Published Clinical Experience Outside of the USA

Other published studies report results from >160 patients treated with ADRCs outside of the USA.

IndicationNumber of PatientsOutcome
Burn scar revision2Rapid healing and satisfactory cosmetic outcome
Breast reconstruction post-lumpectomy71Significant reduction in fibrosis, scarring, and overall breast deformity
Ischemic cardiomyopathy27
(21 treated)
Oxygen consumption capacity declined in placebo but not in ADRC group; significant improvements in total left ventricular mass and wall motion score index with ADRCs
Heart Attack14
(10 treated)
Trend for improvement of infarct size and perfusion defect in treated patients
Stress Urinary Incontinence in Men1136% of subjects improved urinary leakage by more than 50%
Stress Urinary Incontinence in Men6Improved incontinence in 5/6 subjects
Erectile Dysfunction17Improved erectile function in patients who exhibited urinary continence at baseline
Hand function in systemic sclerosis12Improved hand function and reduced disability and fibrosis
Chronic fistula (multiple studies)1-415Healing and closure of several fistulae that had failed to heal and close following standard treatment