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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

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

NCT ID

NCT02869061

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

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

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

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