Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
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ClinicalTrials.gov Identifier: NCT02166489 |
Recruitment Status :
Completed
First Posted : June 18, 2014
Last Update Posted : January 5, 2016
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Condition or disease | Intervention/treatment | Phase |
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Chronic Renal Failure Polycystic Kidney Disease | Biological: Intravenous injection autologous mesenchymal stem cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: mesenchymal stem cell transplantation
Intravenous injection of mesenchymal stem cell in patients with PKD
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Biological: Intravenous injection autologous mesenchymal stem cells
Intravenous injection of mesenchymal stem cell in patients with PKD |
- Mass formation [ Time Frame: 1 month ]Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
- Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166489
Iran, Islamic Republic of | |
Royan Institute | |
Tehran, Iran, Islamic Republic of |
Study Chair: | Hamid Gourabi, PhD | Head of Royan Institute | |
Study Director: | Nasser Aghdami, MD,PhD | Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute | |
Study Director: | Atieh Makhlough, MD | Mazandaran University of Medical Sciences, Mazandaran, Iran. | |
Principal Investigator: | Reza Moghadasali, PhD | Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT02166489 |
Other Study ID Numbers: |
Royan-Kidney-003 |
First Posted: | June 18, 2014 Key Record Dates |
Last Update Posted: | January 5, 2016 |
Last Verified: | November 2015 |
autologous mesenchymal stem cells polycystic kidney disease intravenous injection CRF |
Kidney Diseases Renal Insufficiency Kidney Failure, Chronic Renal Insufficiency, Chronic Polycystic Kidney Diseases Urologic Diseases |
Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Ciliopathies Genetic Diseases, Inborn |