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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 : Recruiting
First Posted : November 10, 2016
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Terry, Glenn C., M.D.
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc

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) 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Outcome measured at 1 month ]
    Report of minor and severe adverse effects caused by the procedures

  2. 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


Secondary Outcome Measures :
  1. Pain on Voiding [ Time Frame: Baseline, 6 month, 1 year ]
    Visual Analog Pain Scale (VAS) designated as levels pain 1-10

  2. 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)

  3. Change in BPH Symptom Score [ Time Frame: Baseline, 6 month, 1 year ]
    Change from Baseline of Measured International Prostate Symptom Score (I-PPS)



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Robert W Alexander, MD, MD 4067774477 rwamd@cybernet1.com
Contact: Susan Riley, CMA 406.777.5312 GARM-USA@gmail.com

Locations
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United States, Montana
Global Alliance for Regenerative Medicine-USA Recruiting
Stevensville, Montana, United States, 59870
Contact: Robert Alexander, MD, CMA    406-777-4477    GARM-USA@gmail.com   
Contact: Nancy L Smith, MA,ORT    406.777.5312    nancy@cybernet1.com   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Regenevita LLC Recruiting
Stevensville, Montana, United States, 59870
Contact: Glenn C Terry, MD    706-566-9141    corky3444@gmail.com   
Contact: Heather Terry    17065669141    info@garm.com.hn   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Sponsors and Collaborators
Robert W. Alexander, MD, FICS
Terry, Glenn C., M.D.

Publications:

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Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Science, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT02961114     History of Changes
Other Study ID Numbers: RGV GARM 4
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Annual Data Update to All Collaborators
Keywords provided by Robert W. Alexander, MD, FICS, Healeon Medical Inc:
Prostatitis, Chronic
Nocturia
BPH With Urinary Obstruction
Additional relevant MeSH terms:
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Prostatitis
Inflammation
Hypertrophy
Nocturia
Prostatism
Pathologic Processes
Pathological Conditions, Anatomical
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male