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This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC recipient | Experimental | The patients with CKD who underwent intravenous injection of MSC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous injection | Biological | Intravenous injection of bone marrow derived MSC in patients with CKD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mass formation | Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection. | 6months |
| Creatinin | Evaluation the rise of creatinin 1 month after cell transplantation. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| GFR | Evaluation the increase of GFR 6 months after cell transplantation with scan isotope . | 6months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of regenerative medicine department &cell therapy center of Royan Institute | Study Director |
| Atieh Makhloogh, MD | Mazandaran University of Medical Sciences, Mazandaran, Iran | Study Director |
| Reza Moghadasali, PhD | Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007275 | Injections, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007267 |
| Injections |