Chronic Renal FailurePhase 1NCT02166489
Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
A Phase 1 study testing Intravenous injection autologous mesenchymal stem cells in people with Chronic Renal Failure and Polycystic Kidney Disease, run by Royan Institute at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Renal Failure, Polycystic Kidney Disease
- What is being tested?
- Intravenous injection autologous mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIran
- Study dates
- Mar 2014to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
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).
Read the 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.
- Conditions
- Chronic Renal Failure, Polycystic Kidney Disease
- Being tested
- Intravenous injection autologous mesenchymal stem cells
- Keywords
- autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF
- Medical subject headings
- Kidney Failure, Chronic, Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection autologous mesenchymal stem cellsBiological
Intravenous injection of mesenchymal stem cell in patients with PKD
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cell transplantation | Experimental | Intravenous injection of mesenchymal stem cell in patients with PKD Receives: Biological: Intravenous injection autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass formation
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
Measured: 1 month
Secondary outcomes (1)
Glomerular Filtration Rate (GFR)
Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Department of Regenerative Medicine & Cell therapy center of Royan InstituteAtieh Makhlough, MD, Study director, Mazandaran University of Medical Sciences, Mazandaran, Iran.Reza Moghadasali, PhD, Principal investigator, Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166489
- Sponsor's protocol ID
- Royan-Kidney-003
- Status last verified
- Nov 2015
- First submitted
- 14 Jun 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28535817
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT02166489
- Acronym / sponsor ID
- Royan-Kidney-003
- Conditions
- Chronic Renal Failure, Polycystic Kidney Disease
- Keywords
- autologous mesenchymal stem cells, polycystic kidney disease, intravenous injection, CRF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cell transplantation | Experimental | Biological: Intravenous injection autologous mesenchymal stem cellsIntravenous injection of mesenchymal stem cell in patients with PKD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous injection autologous mesenchymal stem cellsIntravenous injection of mesenchymal stem cell in patients with PKD | Biological | mesenchymal stem cell transplantation |
Primary outcome
Mass formation
Time frame: 1 month
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
1 secondary outcome
Glomerular Filtration Rate (GFR)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Derived from this study: PubMed 28535817Makhlough 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
Atieh Makhlough, MD study director
Mazandaran University of Medical Sciences, Mazandaran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous injection autologous mesenchymal stem cells in people with Chronic Renal Failure and Polycystic Kidney Disease, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass formation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.