Clinical trial NCT02166489: Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
Official title: Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Renal Failure
Polycystic Kidney Disease
Keywords: autologous mesenchymal stem cells
polycystic kidney disease
intravenous injection
CRF
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-06-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).

Detailed description: The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope.

Eligibility criteria: 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

Primary outcomes:
measure: Mass formation
timeFrame: 1 month
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Mazandaran University of Medical Sciences, Mazandaran, Iran.
name: Atieh Makhlough, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
name: Reza Moghadasali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makhlough A, Shekarchian S, Moghadasali R, Einollahi B, Hosseini SE, Jaroughi N, Bolurieh T, Baharvand H, Aghdami N. Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients. Stem Cell Res Ther. 2017 May 23;8(1):116. doi: 10.1186/s13287-017-0557-7.