Protocol summary

Summary
Objectives: This project intends to evaluate, up to 6 months, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltartion failure. Design: In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Setting and conduct, participants and intervention: Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a small sample of fat tissue will be obtained by a general surgeon under sterilized condition frompatients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052415841N2
Registration date: 2015-07-19, 1394/04/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Gholamreza Pourmand
Name of organization / entity
Urology Research Center,Tehran University of Medical Sciences,Tehran,Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
pourmand@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical effects of mesenchymal stem cell therapy in peritoneal dialysis patients with ultrafiltration failure, a clinical trial
Public title
Effects of mesenchymal stem cells therapy in peritoneal dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients on peritoneal dialysis; Both sexes; Age between 18-70 years; Being on peritoneal dialysis for at least last two years; Having Ultrafiltration failure Exclusion criteria: Patients who cannot come for regular visits; Patients with less than 1 year survival; Patients on immunosuppressive medications; Pregnancy; Malignancy; Coagulative disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sciences Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, central building of TUMS, Ghods street, Keshavarz Blv, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
IR.TUMS.REC.1394.326

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
D/P cr
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
Ratio of 4-hour dialysate/plasma creatinine

2

Description
D/P urea
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
Ratio of 4-hour dialysate/plasma urea

3

Description
D0/D glucose
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
Ratio of dialysate glucose concentrations at end and at start of tests

4

Description
Peritoneal Equilibration Test (PET)
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
Assessment of peritoneal membrane transport function by machine

Secondary outcomes

1

Description
Glomerular filtration rate (GFR)
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
MDRD formula

2

Description
Kt/V urea
Timepoint
Before and at week 3, week 6, month 3, month 4 and month 6
Method of measurement
Dialyzer clearance of urea * dialysis time/ volume of distribution of urea

Intervention groups

1

Description
Historical control: no intervention or injection will be done in this group.
Category
Treatment - Drugs

2

Description
Intervention group: Single peripheral injection of autologous mesenchymal stem cells (1,000,000/kg). The mesenchymal stem cells will be separated from fat tissue and then the cells will be cultured and proliferated in specialized lab until they reach enough numbers and then they will be injected through peripheral. The injection will be performed only one time.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati Hospital, Nephrology Research Center
Full name of responsible person
Dr Sudabeh Alatab
Street address
4th floor, Dr. Shariati Hospital, North Karger Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
6th floor, Central building of TUMS, Ghods street, Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urology Research Center,Tehran University of Meical Scienses
Full name of responsible person
Dr. Sudabeh Alatab
Position
Medical Doctor
Other areas of specialty/work
Street address
Urology Research Cente, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
Email
sudabehalatab@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Pourmand
Position
Urologist
Other areas of specialty/work
Street address
Urology Research Center, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
Email
gh_pourmand@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urology Research Center,Tehran University of Medical Sciences
Full name of responsible person
Dr. Sudabeh Alatab
Position
MD
Other areas of specialty/work
Street address
Urology Research Center, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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