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.
|Indication||Trial||Design||Number of Patients||Number of Sites||Results|
|Heart Failure||ATHENA*||Randomized (1:1), placebo-controlled, double-blind||30||9||Improvement in health-related quality of life|
|Osteoarthritis of the knee||ACT-OA||Randomized (2:1), placebo-controlled, double-blind||94||12||Trends favored treatment arm in pain and use of pain medication and in MRI of the joint|
|Hand Function in the autoimmune disease scleroderma||STAR||Randomized (1:1), placebo-controlled, double-blind||88||19||Clinically-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.
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.
|Indication||Number of Patients||Outcome|
|Burn scar revision||2||Rapid healing and satisfactory cosmetic outcome|
|Breast reconstruction post-lumpectomy||71||Significant reduction in fibrosis, scarring, and overall breast deformity|
|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|
|Trend for improvement of infarct size and perfusion defect in treated patients|
|Stress Urinary Incontinence in Men||11||36% of subjects improved urinary leakage by more than 50%|
|Stress Urinary Incontinence in Men||6||Improved incontinence in 5/6 subjects|
|Erectile Dysfunction||17||Improved erectile function in patients who exhibited urinary continence at baseline|
|Hand function in systemic sclerosis||12||Improved hand function and reduced disability and fibrosis|
|Chronic fistula (multiple studies)1-4||15||Healing and closure of several fistulae that had failed to heal and close following standard treatment|