Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy (SVF-BPN)
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|ClinicalTrials.gov Identifier: NCT02961114|
Recruitment Status : Withdrawn (COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform)
First Posted : November 10, 2016
Last Update Posted : January 12, 2021
Benign prostate hypertrophy (BPH) and inflammation are common non-cancerous enlargement of the prostate, which result in urinary interference and incomplete drainage of the bladder. Compression of the urethra is common cause of such resistance of full draining, and may over time result in progressive hypertrophy, instability, urgency, nocturia and weakness of the bladder musculature.
Prostatic growth frequently begins in the 30s, and it is estimated that 50% of all males have benign enlargement leading to 75% by age 80. BPH and low grade inflammation is one of the ten most prominent and costly disorders in males over 50.
Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms can be associated with bladder outlet obstruction (BOO).
This study utilizes isolation of adipose-derived stem/stromal cellular stromal vascular fraction (AD-cSVF) deployed as an IV suspension in sterile Normal Saline (500cc). Due to the anti-inflammatory and immunomodulatory effects common to AD-cSVF are tested in relief of the inflammatory elements and the concurrent hypertrophy in BPH. Early pilot use has suggested a positive effect on these issues, and have relieved much of the incomplete voiding, pain, nocturia, delay in starting/stopping urination, and increased urgency and frequency.
Lipoharvesting of Adipose-Derived tissue stromal vascular fraction (AD-tSVF) is now a common closed access to subdermal adipose stromal/stem cell population consisting of both stem and stromal cells, each of which are felt to contribute a wide variety of effects and potentials. Closed, sterile isolation of the AD-cSVF is possible with advent of closed systems to enzymatically release these cells from the actual matrix (scaffolding) within the adipose tissue complex (ATC). This group of largely un-designated cell population is isolated and concentrated via a standard gradient layer separation by centrifugation. This cellular isolate is then suspended in an IV of 500 cc Normal Saline and reintroduced to the patient.
This study is examining the clinical safety and efficacy of this approach, as well as tracking the duration of effects and establish a therapeutic interval.
|Condition or disease||Intervention/treatment||Phase|
|BPH Nocturia BPH With Urinary Obstruction Prostatism Prostate Inflammation||Procedure: Microcannula Harvest Adipose Device: Centricyte 1000 Biological: IV Sterile Normal Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||July 2023|
Experimental: Microcannula Harvest Adipose
Acquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits
Procedure: Microcannula Harvest Adipose
Use of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF
Experimental: Centricyte 1000
Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF
Device: Centricyte 1000
Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF
Experimental: IV Sterile Normal Saline
Re-suspension of AD-cSVF pellet in Normal Saline for deployment via IV
Biological: IV Sterile Normal Saline
Sterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway
- Adverse Events [ Time Frame: Outcome measured at 1 month ]Report of minor and severe adverse effects caused by the procedures
- Clinical Symptom Changes [ Time Frame: Baseline, 1 Month, 6 Months, 1 years ]Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding
- Pain on Voiding [ Time Frame: Baseline, 6 month, 1 year ]Visual Analog Pain Scale (VAS) designated as levels pain 1-10
- Change of BPH Symptom Score [ Time Frame: Baseline, 6 month, 12 month ]BPH Symptom Score change from baseline use American Urological Association Symptom Score Index change from baseline using Amercian Urological Association Symptom Score Index (AUA SI)
- Change in BPH Symptom Score [ Time Frame: Baseline, 6 month, 1 year ]Change from Baseline of Measured International Prostate Symptom Score (I-PPS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961114
|United States, Montana|
|Global Alliance for Regenerative Medicine-USA|
|Stevensville, Montana, United States, 59870|
|Stevensville, Montana, United States, 59870|