Objective: Safety and feasibility of using bone marrow-derived mesenchymal stem cells for treatment chronic renal failure.
Design: Study groups: Ten CKD patients. Groups: One group, phase I. Sample size: Ten patients. Blinding: Not blinded, single center. Method: After trial description and obtaining informed consent, bone marrow aspiration will be performed and mesenchymal stem cells will be isolated and cultivated in clean room, then 1 million/kg cells in one dose will be injected into a peripheral vein of patients. Patients at first week, second week, one month and then every 3 months until 12 months after the injection will be followed up clinically and para-clinically. The trends of kidney function (serum creatinine and GFR) in last year before injection for each patient will be regarded as the control for that patient.
Inclusion/exclusion criteria: Main inclusion criteria include CKD patients with glomerular filtration rate between 25-60 ml/min. Patients with diabetes, congestive heart failure, malignancy will be excluded from the trial.
Intervention: One dose of peripheral vein infusion of bone marrow derived mesenchymal stem cell.
The primary endpoint will be evaluated as the injection adverse event and changes in renal function, periodic assessments of serum BUN and creatinine and GFR as secondary endpoints of the study will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509031031N17
Registration date:2015-12-09, 1394/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A phase I clinical trial on the use of autologous bone marrow mesenchymal stem cells for treatment of chronic kidney disease
Public title
Use of stem cells for treatment of chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: CKD confirmed with serum and urine analysis and GFR 25-60 mL/min; Male and Female; CKD (more than 3 months with increased and irreversible creatinine) symptoms; Patients with controlled hypertension; Patient's age between 40-60 years; Ability to understand and willingness to sign consent form
Exclusion Criteria: Pregnant or lactating; Vascular disease; Diabetes mellitus; Other systemic disease such as malignancy, autoimmune disease, hematologic disease, liver disease and …; Chronic rejection in transplantation; Life expectancy less than 2 years; Allergy to any ingredients used in cell culture; Congenital or acquired obstructive chronic renal failure; Unable to attend at follow up visits
Age
From 40 years old to 60 years old
Gender
Both
Phase
1
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
No other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT02195323
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2014-08-12, 1393/05/21
Ethics committee reference number
EC/93/1052
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
I12
ICD-10 code description
Hypertensive renal disease
Primary outcomes
1
Description
Mass formation
Timepoint
Every three months
Method of measurement
Sonography
2
Description
Creatinine
Timepoint
1,3,6,9,12 months after cell transplantation
Method of measurement
Blood Test
Secondary outcomes
1
Description
eGFR
Timepoint
1,3,6,9,12 months after cell transplantation
Method of measurement
Scan isotope and GFR formula
Intervention groups
1
Description
Intervention group: One dose intravenous injection of 1 million/kg bone marrow derived MSC in patients with CKD
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Khomeini Hospital
Full name of responsible person
Atieh Makhlough
Street address
Sari, Imam Khomeini Hospital, Beginning of Vali Asr Highway, Jouybar Three-way, Imam Square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell
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
Royan Institute
Full name of responsible person
Soroosh Shekarchian
Position
M.D/Researcher
Other areas of specialty/work
Street address
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
soroosh.shekarchian@royaninstitute.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nasser Aghdami
Position
M.D/Ph.D
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
Researcher/M.D
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
+98 21 2251 6465
Email
hoda62_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)