Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy (SVF-BPN)

January 9, 2021 updated by: Robert W. Alexander, MD, FICS

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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, moderating alcohol and caffeine, decrease certain anticholinergic medications. Use of medication have some advantages, including alpha blocker and 5 alpha-reductase inhibitors, and some broad spectrum antibiotics (like Ciprofloxacin) seem to help many of those with increasing symptoms. Self catheterization and surgery are occasionally needed for patient comfort and reduction of symptomatology.

Alternative remedies include herbal remedies (saw palmetto) and anecdotal effects in patients receiving parenteral stem/stromal cell therapies for other clinical issues. Initially commented that the patient reported improvement of symptoms, have led to this study to determine if any long-interval therapy may be as effective as surgery or catheterization.

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Global Alliance for Regenerative Medicine-USA
      • Stevensville, Montana, United States, 59870
        • Regenevita LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Outcome measured at 1 month
Report of minor and severe adverse effects caused by the procedures
Outcome measured at 1 month
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
Baseline, 1 Month, 6 Months, 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on Voiding
Time Frame: Baseline, 6 month, 1 year
Visual Analog Pain Scale (VAS) designated as levels pain 1-10
Baseline, 6 month, 1 year
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)
Baseline, 6 month, 12 month
Change in BPH Symptom Score
Time Frame: Baseline, 6 month, 1 year
Change from Baseline of Measured International Prostate Symptom Score (I-PPS)
Baseline, 6 month, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert W. Alexander, MD, FICS

Collaborators

Terry, Glenn C., M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGV GARM 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Annual Data Update to All Collaborators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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