Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Clinical Symptom Changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented history BPH for at least 1 year
- •AUA SI greater than or equal to score of 15
- •Qmax < 15 ml/sec
- •Severe nocturia
- •Prostate Specific Antigen (PSA) > 4 ng/mL with documentation of non-malignancy
排除标准
- •History of illness or conditions that may interfere with study or endanger subject
- •Use of prescription medication that may interfere with study or endanger subject within 30 days
- •History of surgical procedures for BPH or documented prostate cancer
- •Post-void residual urine volumes of > 350 cc
- •PSA > 10 ng/mL
- •Prostate cancer not ruled out by biopsy if PSA is consistently higher than 4 ng/mL
结局指标
主要结局
Clinical Symptom Changes
时间窗: Baseline, 1 Month, 6 Months, 1 years
Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding
Adverse Events
时间窗: Outcome measured at 1 month
Report of minor and severe adverse effects caused by the procedures
次要结局
- Change of BPH Symptom Score(Baseline, 6 month, 12 month)
- Change in BPH Symptom Score(Baseline, 6 month, 1 year)
- Pain on Voiding(Baseline, 6 month, 1 year)
研究者
Robert W. Alexander, MD, FICS
Principal Investigator, Science
Healeon Medical Inc