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Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture

Primary Purpose

Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Liposuction
Transurethral bladder neck resection.
ADRC
ADRC isolation
Sponsored by
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Neck Obstruction focused on measuring Bladder neck obstruction, Bladder outlet obstruction, Benign prostatic hyperplasia, Urinary bladder neck obstruction, Bladder neck contracture, Bladder neck stricture, Bladder neck stenosis, Transurethral resection of the prostate, Prostatectomy, Stromal vascular fraction (SVF), Adipose-derived regenerative cells (ADRC), Adipose tissue, Stem cells

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Bladder neck contracture after transurethral prostate resection.
  • Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s
  • Patient is familiar with Participant information sheet
  • Patient signed informed consent form

Non-inclusion Criteria:

  • Contraindications for spinal, epidural or inhalation anesthesia
  • Urethral strictures
  • Genitourinary inflammatory diseases
  • Prostate-specific antigen (PSA) level above 4 ng/mL
  • Contraindications for local anesthesia or history of allergy for local anesthetics
  • Systemic glucocorticoid and/or immunosuppressant therapy
  • Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
  • Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
  • Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
  • Clinically significant abnormalities in results of laboratory tests
  • Patient received anticoagulants at least 12 hours prior the liposuction
  • Medical history of heterotopic ossifications
  • Patients prescribed for glycoprotein inhibitors treatment

Exclusion Criteria:

  • Patient's refusal from the further participation in trial
  • Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
  • Confirmed syphilis, HIV, hepatitis B or C infections

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University
  • Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADRC injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)

Secondary Outcome Measures

Changes of the volume of residual urine
Influence of the procedure on the volume of residual urine assessed by ultrasonography
Urodynamic changes - 1
Influence of the intervention on urinary flow rate: maximum flow rate
Urodynamic changes - 2
Influence of the intervention on urinary flow rate: average flow rate
Urodynamic changes - 3
Influence of the intervention on urinary flow rate: total volume voided
Urodynamic changes - 4
Influence of the intervention on urinary flow rate: maximum flow time
Quality of life monitoring - 1
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Quality of life monitoring - 2
Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).
Bladder neck restenosis control
Revision of bladder neck structure by retrograde urethrography

Full Information

First Posted
August 8, 2016
Last Updated
August 11, 2016
Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Collaborators
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02869061
Brief Title
Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture
Official Title
Effectiveness and Safety of Local Endoscopically-assisted Administration of Autologous Adipose-derived Regenerative Cells for Reduction of Risk of Postoperative Bladder Neck Contracture in Male Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Collaborators
I.M. Sechenov First Moscow State Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia, Urinary Bladder Neck Obstruction
Keywords
Bladder neck obstruction, Bladder outlet obstruction, Benign prostatic hyperplasia, Urinary bladder neck obstruction, Bladder neck contracture, Bladder neck stricture, Bladder neck stenosis, Transurethral resection of the prostate, Prostatectomy, Stromal vascular fraction (SVF), Adipose-derived regenerative cells (ADRC), Adipose tissue, Stem cells

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADRC injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Type
Procedure
Intervention Name(s)
Transurethral bladder neck resection.
Intervention Type
Biological
Intervention Name(s)
ADRC
Other Intervention Name(s)
Adipose-derived regenerative cells
Intervention Description
Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.
Intervention Type
Other
Intervention Name(s)
ADRC isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serious adverse events
Description
Frequency, type and severity of serious adverse events (SAE)
Time Frame
4 weeks after injection of ADRC suspension
Title
Serious adverse reactions
Description
Frequency, type and severity of serious adverse reactions (SAR)
Time Frame
Time Frame: 4 weeks after injection of ADRC suspension
Secondary Outcome Measure Information:
Title
Changes of the volume of residual urine
Description
Influence of the procedure on the volume of residual urine assessed by ultrasonography
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Urodynamic changes - 1
Description
Influence of the intervention on urinary flow rate: maximum flow rate
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Urodynamic changes - 2
Description
Influence of the intervention on urinary flow rate: average flow rate
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Urodynamic changes - 3
Description
Influence of the intervention on urinary flow rate: total volume voided
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Urodynamic changes - 4
Description
Influence of the intervention on urinary flow rate: maximum flow time
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Quality of life monitoring - 1
Description
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Quality of life monitoring - 2
Description
Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).
Time Frame
Follow up to completion (48 weeks after intervention)
Title
Bladder neck restenosis control
Description
Revision of bladder neck structure by retrograde urethrography
Time Frame
Follow up to completion (48 weeks after intervention)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bladder neck contracture after transurethral prostate resection. Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s Patient is familiar with Participant information sheet Patient signed informed consent form Non-inclusion Criteria: Contraindications for spinal, epidural or inhalation anesthesia Urethral strictures Genitourinary inflammatory diseases Prostate-specific antigen (PSA) level above 4 ng/mL Contraindications for local anesthesia or history of allergy for local anesthetics Systemic glucocorticoid and/or immunosuppressant therapy Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.) Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy Clinically significant abnormalities in results of laboratory tests Patient received anticoagulants at least 12 hours prior the liposuction Medical history of heterotopic ossifications Patients prescribed for glycoprotein inhibitors treatment Exclusion Criteria: Patient's refusal from the further participation in trial Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula) Confirmed syphilis, HIV, hepatitis B or C infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis V Butnaru, MD, PhD
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey A Pulin, MD, PhD
Organizational Affiliation
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey Z Vinarov, MD, PhD, Prof
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture

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