Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy (SVF-BPN)
Primary Purpose
BPH, Nocturia, BPH With Urinary Obstruction
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Microcannula Harvest Adipose
Centricyte 1000
IV Sterile Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for BPH focused on measuring Prostatitis, Chronic, Nocturia, BPH With Urinary Obstruction
Eligibility 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
Sites / Locations
- Global Alliance for Regenerative Medicine-USA
- Regenevita LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Microcannula Harvest Adipose
Centricyte 1000
IV Sterile Normal Saline
Arm Description
Acquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits
Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF
Re-suspension of AD-cSVF pellet in Normal Saline for deployment via IV
Outcomes
Primary Outcome Measures
Adverse Events
Report of minor and severe adverse effects caused by the procedures
Clinical Symptom Changes
Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding
Secondary Outcome Measures
Pain on Voiding
Visual Analog Pain Scale (VAS) designated as levels pain 1-10
Change of BPH Symptom Score
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
Change from Baseline of Measured International Prostate Symptom Score (I-PPS)
Full Information
NCT ID
NCT02961114
First Posted
November 8, 2016
Last Updated
January 9, 2021
Sponsor
Robert W. Alexander, MD, FICS
Collaborators
Terry, Glenn C., M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02961114
Brief Title
Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
Acronym
SVF-BPN
Official Title
Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert W. Alexander, MD, FICS
Collaborators
Terry, Glenn C., M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH, Nocturia, BPH With Urinary Obstruction, Prostatism, Prostate Inflammation
Keywords
Prostatitis, Chronic, Nocturia, BPH With Urinary Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microcannula Harvest Adipose
Arm Type
Experimental
Arm Description
Acquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits
Arm Title
Centricyte 1000
Arm Type
Experimental
Arm Description
Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF
Arm Title
IV Sterile Normal Saline
Arm Type
Experimental
Arm Description
Re-suspension of AD-cSVF pellet in Normal Saline for deployment via IV
Intervention Type
Procedure
Intervention Name(s)
Microcannula Harvest Adipose
Intervention Description
Use of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF
Intervention Type
Device
Intervention Name(s)
Centricyte 1000
Intervention Description
Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF
Intervention Type
Biological
Intervention Name(s)
IV Sterile Normal Saline
Intervention Description
Sterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway
Primary Outcome Measure Information:
Title
Adverse Events
Description
Report of minor and severe adverse effects caused by the procedures
Time Frame
Outcome measured at 1 month
Title
Clinical Symptom Changes
Description
Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding
Time Frame
Baseline, 1 Month, 6 Months, 1 years
Secondary Outcome Measure Information:
Title
Pain on Voiding
Description
Visual Analog Pain Scale (VAS) designated as levels pain 1-10
Time Frame
Baseline, 6 month, 1 year
Title
Change of BPH Symptom Score
Description
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)
Time Frame
Baseline, 6 month, 12 month
Title
Change in BPH Symptom Score
Description
Change from Baseline of Measured International Prostate Symptom Score (I-PPS)
Time Frame
Baseline, 6 month, 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Global Alliance for Regenerative Medicine-USA
City
Stevensville
State/Province
Montana
ZIP/Postal Code
59870
Country
United States
Facility Name
Regenevita LLC
City
Stevensville
State/Province
Montana
ZIP/Postal Code
59870
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Annual Data Update to All Collaborators
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Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
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