Clinical Trial: Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy

Brief Summary:

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)

Detailed Summary:

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. BPH is often a progressive disease and may lead to increased urinary stasis and increased risk of urinary tract infections.

Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms can be associated with bladder outlet obstruction (BOO). Storage symptoms include need to urinate frequently, waking at night to urinate (nocturia), and incontinence (involuntary). Voiding issues include urinary hesitancy, intermittency (start/stopping flow), leaking after voiding and may include some pain (dysuria) associated with urination. Post-voiding symptoms include abdominal pain, feeling of full bladder, acute urinary retention and frequency, dysuria, hesitancy, etc.

Causation may be associated with age related changes in androgens (such as testosterone and others), but do not seem to be the direct cause of the enlargement.

Androgens promote prostate cell proliferation, but relatively low levels of testosterone are often found in patients with BPH.

Treatment often has been aimed at lifestyle change (exercise, decrease nighttime fluid intake
Sponsor: Robert W. Alexander, MD, FICS

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Healeon Medical Inc

Dates:
Date Received: November 8, 2016
Date Started: November 2016
Date Completion: July 2019
Last Updated: February 15, 2017
Last Verified: February 2017