A Phase 1/2 interventional study of Liposuction and Transurethral bladder neck resection. in Bladder Neck Obstruction, Bladder Outlet Obstruction and Benign Prostatic Hyperplasia, sponsored by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation. Status unknown at 2 sites in Russian Federation. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-16.
Sponsored by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Phase 1/2, Interventional, and Prevention
Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion from a portion of the fat harvested from the patient's front abdominal wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 9.5 ml of normal saline.Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (9 ml) placed into sterile syringe for injection.
Surgery:
Transurethral endoscopic loop resection of bladder neck will be performed.
Autologous ADRC administration:
Injection of ADRC suspension will be performed immediately after bladder neck resection. 9 to 18 injections (0.5 to 1.0 mL each) will be injected with endoscopic needle into the bladder neck close to the site of resection. All injections will be performed during single procedure.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's planned enrollment of 12 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The human immunodeficiency virus, which weakens the immune system.
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Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be undergone liposuction under local anesthesia. Adipose-derived regenerative cells (ADRC) will be isolated from lipoaspirate by enzymatic digestion. Transurethral bladder neck resection followed by the injection of ADRC suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.
Procedure: Liposuction · Procedure: Transurethral bladder neck resection. · Biological: ADRC · Other: ADRC isolation
Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.
Also known as: Adipose-derived regenerative cells
ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in up to 9.5 ml of normal saline.
Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Time frame: 4 weeks after injection of ADRC suspension
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Time frame: Time Frame: 4 weeks after injection of ADRC suspension
Changes of the volume of residual urine
Influence of the procedure on the volume of residual urine assessed by ultrasonography
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 1
Influence of the intervention on urinary flow rate: maximum flow rate
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 2
Influence of the intervention on urinary flow rate: average flow rate
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 3
Influence of the intervention on urinary flow rate: total volume voided
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 4
Influence of the intervention on urinary flow rate: maximum flow time
Time frame: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 1
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Time frame: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 2
Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).
Time frame: Follow up to completion (48 weeks after intervention)
Bladder neck restenosis control
Revision of bladder neck structure by retrograde urethrography
Time frame: Follow up to completion (48 weeks after intervention)
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jan 2016, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adipose-Derived Regenerative Cells
Urinary Bladder Neck Obstruction →
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation