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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT02166489 |
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Date of registration:
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14/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
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Scientific title:
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Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02166489 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Reza Moghadasali, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology |
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Name:
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Hamid Gourabi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Royan Institute |
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Name:
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Atieh Makhlough, MD |
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Address:
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Email:
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Affiliation:
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Mazandaran University of Medical Sciences, Mazandaran, Iran. |
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Name:
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Nasser Aghdami, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and Female
- ADPKD symptoms
- ADPKD confirmed with sonography and genetic testing
- Patient's age between 18 - 60 years
- GFR GFR 25-60 mL/min/1.73 m2
- Ability to understand and willingness to sign consent from
Exclusion Criteria:
- Pregnancy or breastfeeding
- Associated Cardiovascular disease
- Diabetes requiring medical intervention
- Other systemic diseases involving the kidneys, such as cancer, autoimmune diseases,
blood diseases, liver disease, etc.
- Hospitalization due to illness in the last two months
- Life expectancy of less than two years
- Any allergies to the ingredients used in the cell culture
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Renal Failure
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Polycystic Kidney Disease
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Intervention(s)
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Biological: Intravenous injection autologous mesenchymal stem cells
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Primary Outcome(s)
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Mass formation
[Time Frame: 1 month]
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Secondary Outcome(s)
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Glomerular Filtration Rate (GFR)
[Time Frame: 6 months]
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Secondary ID(s)
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Royan-Kidney-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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