BPHPhase 1/2SVF-BPNNCT02961114
Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
A Phase 1/2 study testing Microcannula Harvest Adipose, Centricyte 1000 and IV Sterile Normal Saline in people with BPH and Nocturia, run by Robert W. Alexander, MD, FICS at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- BPH, Nocturia, BPH With Urinary Obstruction
- What is being tested?
- Microcannula Harvest Adipose, Centricyte 1000 and IV Sterile Normal Saline
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2019to Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Global Alliance for Regenerative Medicine-USA
Stevensville, Montana, 59870
Regenevita LLC
Stevensville, Montana, 59870
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- BPH, Nocturia, BPH With Urinary Obstruction, Prostatism, Prostate Inflammation
- Being tested
- Microcannula Harvest Adipose, Centricyte 1000, IV Sterile Normal Saline
- Keywords
- Prostatitis, Chronic, Nocturia, BPH With Urinary Obstruction
- Medical subject headings
- Nocturia, Prostatism, Prostatitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcannula Harvest AdiposeProcedure or surgery
Use of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF
Centricyte 1000Device
Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF
IV Sterile Normal SalineBiological
Sterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway
| Study group | Role | What they receive |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Acquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits Receives: Procedure: Microcannula Harvest Adipose |
| Centricyte 1000 | Experimental | Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF Receives: Device: Centricyte 1000 |
| IV Sterile Normal Saline | Experimental | Re-suspension of AD-cSVF pellet in Normal Saline for deployment via IV Receives: Biological: IV Sterile Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Report of minor and severe adverse effects caused by the procedures
Measured: Outcome measured at 1 month
Clinical Symptom Changes
Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding
Measured: Baseline, 1 Month, 6 Months, 1 years
Secondary outcomes (3)
Pain on Voiding
Visual Analog Pain Scale (VAS) designated as levels pain 1-10
Measured: Baseline, 6 month, 1 year
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)
Measured: Baseline, 6 month, 12 month
Change in BPH Symptom Score
Change from Baseline of Measured International Prostate Symptom Score (I-PPS)
Measured: Baseline, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start1 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert W. Alexander, MD, FICS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Terry, Glenn C., M.D.
- Responsible party
- Sponsor-investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961114
- Sponsor's protocol ID
- RGV GARM 4
- Acronym
- SVF-BPN
- Status last verified
- Jan 2021
- First submitted
- 8 Nov 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Annual Data Update to All Collaborators
Publications
Chang RT, Kirby R, Challacombe BJ. Is there a link between BPH and prostate cancer? Practitioner. 2012 Apr;256(1750):13-6, 2.
PubMed 22792684Guess HA, Arrighi HM, Metter EJ, Fozard JL. Cumulative prevalence of prostatism matches the autopsy prevalence of benign prostatic hyperplasia. Prostate. 1990;17(3):241-6. doi: 10.1002/pros.2990170308.
PubMed 1700403Fenter TC, Naslund MJ, Shah MB, Eaddy MT, Black L. The cost of treating the 10 most prevalent diseases in men 50 years of age or older. Am J Manag Care. 2006 Mar;12(4 Suppl):S90-8.
PubMed 16551207White JM JR, O'Brien DP III. Incontinence and Stream Abnormalities. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 185. Available from http://www.ncbi.nlm.nih.gov/books/NBK295/
PubMed 21250138Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012 Jul 19;367(3):248-57. doi: 10.1056/NEJMcp1106637. No abstract available.
PubMed 22808960Bartsch G, Rittmaster RS, Klocker H. Dihydrotestosterone and the concept of 5alpha-reductase inhibition in human benign prostatic hyperplasia. World J Urol. 2002 Apr;19(6):413-25. doi: 10.1007/s00345-002-0248-5.
PubMed 12022710Lagiou P, Mantzoros CS, Tzonou A, Signorello LB, Lipworth L, Trichopoulos D. Serum steroids in relation to benign prostatic hyperplasia. Oncology. 1997 Nov-Dec;54(6):497-501. doi: 10.1159/000227609.
PubMed 9394847Roberts RO, Jacobson DJ, Rhodes T, Klee GG, Leiber MM, Jacobsen SJ. Serum sex hormones and measures of benign prostatic hyperplasia. Prostate. 2004 Oct 1;61(2):124-31. doi: 10.1002/pros.20080.
PubMed 15305335Ho CK, Nanda J, Chapman KE, Habib FK. Oestrogen and benign prostatic hyperplasia: effects on stromal cell proliferation and local formation from androgen. J Endocrinol. 2008 Jun;197(3):483-91. doi: 10.1677/JOE-07-0470.
PubMed 18492814Niu YJ, Ma TX, Zhang J, Xu Y, Han RF, Sun G. Androgen and prostatic stroma. Asian J Androl. 2003 Mar;5(1):19-26.
PubMed 12646998Chyou PH, Nomura AM, Stemmermann GN, Hankin JH. A prospective study of alcohol, diet, and other lifestyle factors in relation to obstructive uropathy. Prostate. 1993;22(3):253-64. doi: 10.1002/pros.2990220308.
PubMed 7683816Wasserman NF. Benign prostatic hyperplasia: a review and ultrasound classification. Radiol Clin North Am. 2006 Sep;44(5):689-710, viii. doi: 10.1016/j.rcl.2006.07.005.
PubMed 17030221Parsons JK. Benign Prostatic Hyperplasia and Male Lower Urinary Tract Symptoms: Epidemiology and Risk Factors. Curr Bladder Dysfunct Rep. 2010 Dec;5(4):212-218. doi: 10.1007/s11884-010-0067-2. Epub 2010 Sep 7.
PubMed 21475707Silva J, Silva CM, Cruz F. Current medical treatment of lower urinary tract symptoms/BPH: do we have a standard? Curr Opin Urol. 2014 Jan;24(1):21-8. doi: 10.1097/MOU.0000000000000007.
PubMed 24231531Roehrborn CG, Boyle P, Nickel JC, Hoefner K, Andriole G; ARIA3001 ARIA3002 and ARIA3003 Study Investigators. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology. 2002 Sep;60(3):434-41. doi: 10.1016/s0090-4295(02)01905-2.
PubMed 12350480
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy
- ClinicalTrials.gov ID
- NCT02961114
- Acronym / sponsor ID
- SVF-BPN / RGV GARM 4
- Conditions
- BPH, Nocturia, BPH With Urinary Obstruction, Prostatism, Prostate Inflammation
- Keywords
- Prostatitis, Chronic, Nocturia, BPH With Urinary Obstruction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Robert W. Alexander, MD, FICSIndustry (pharma, biotech, devices)
- Collaborators
- Terry, Glenn C., M.D.
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Procedure: Microcannula Harvest AdiposeAcquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits |
| Centricyte 1000 | Experimental | Device: Centricyte 1000Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF |
| IV Sterile Normal Saline | Experimental | Biological: IV Sterile Normal SalineRe-suspension of AD-cSVF pellet in Normal Saline for deployment via IV |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcannula Harvest AdiposeUse of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF | Procedure or surgery | Microcannula Harvest Adipose |
| Centricyte 1000Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF | Device | Centricyte 1000 |
| IV Sterile Normal SalineSterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway | Biological | IV Sterile Normal Saline |
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
3 secondary outcomes
Pain on Voiding
Time frame: Baseline, 6 month, 1 year
Change of BPH Symptom Score
Time frame: Baseline, 6 month, 12 month
Change in BPH Symptom Score
Time frame: Baseline, 6 month, 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 22792684Chang RT, Kirby R, Challacombe BJ. Is there a link between BPH and prostate cancer? Practitioner. 2012 Apr;256(1750):13-6, 2.
- Background: PubMed 1700403Guess HA, Arrighi HM, Metter EJ, Fozard JL. Cumulative prevalence of prostatism matches the autopsy prevalence of benign prostatic hyperplasia. Prostate. 1990;17(3):241-6. doi: 10.1002/pros.2990170308.
- Background: PubMed 16551207Fenter TC, Naslund MJ, Shah MB, Eaddy MT, Black L. The cost of treating the 10 most prevalent diseases in men 50 years of age or older. Am J Manag Care. 2006 Mar;12(4 Suppl):S90-8.
- Background: PubMed 21250138White JM JR, O'Brien DP III. Incontinence and Stream Abnormalities. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 185. Available from http://www.ncbi.nlm.nih.gov/books/NBK295/
- Background: PubMed 22808960Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012 Jul 19;367(3):248-57. doi: 10.1056/NEJMcp1106637. No abstract available.
- Background: PubMed 12022710Bartsch G, Rittmaster RS, Klocker H. Dihydrotestosterone and the concept of 5alpha-reductase inhibition in human benign prostatic hyperplasia. World J Urol. 2002 Apr;19(6):413-25. doi: 10.1007/s00345-002-0248-5.
- Background: PubMed 9394847Lagiou P, Mantzoros CS, Tzonou A, Signorello LB, Lipworth L, Trichopoulos D. Serum steroids in relation to benign prostatic hyperplasia. Oncology. 1997 Nov-Dec;54(6):497-501. doi: 10.1159/000227609.
- Background: PubMed 15305335Roberts RO, Jacobson DJ, Rhodes T, Klee GG, Leiber MM, Jacobsen SJ. Serum sex hormones and measures of benign prostatic hyperplasia. Prostate. 2004 Oct 1;61(2):124-31. doi: 10.1002/pros.20080.
- Background: PubMed 18492814Ho CK, Nanda J, Chapman KE, Habib FK. Oestrogen and benign prostatic hyperplasia: effects on stromal cell proliferation and local formation from androgen. J Endocrinol. 2008 Jun;197(3):483-91. doi: 10.1677/JOE-07-0470.
- Background: PubMed 12646998Niu YJ, Ma TX, Zhang J, Xu Y, Han RF, Sun G. Androgen and prostatic stroma. Asian J Androl. 2003 Mar;5(1):19-26.
- Background: PubMed 7683816Chyou PH, Nomura AM, Stemmermann GN, Hankin JH. A prospective study of alcohol, diet, and other lifestyle factors in relation to obstructive uropathy. Prostate. 1993;22(3):253-64. doi: 10.1002/pros.2990220308.
- Background: PubMed 17030221Wasserman NF. Benign prostatic hyperplasia: a review and ultrasound classification. Radiol Clin North Am. 2006 Sep;44(5):689-710, viii. doi: 10.1016/j.rcl.2006.07.005.
- Individual participant dataSharing planned: Yes. Annual Data Update to All Collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Microcannula Harvest Adipose, Centricyte 1000 and IV Sterile Normal Saline in people with BPH and Nocturia, run by Robert W. Alexander, MD, FICS at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Outcome measured at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02961114, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.