Chronic Kidney DiseasePhase 1NCT02195323
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
A Phase 1 study testing Intravenous injection in people with Chronic 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 kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Intravenous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIran
- Study dates
- Apr 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female
- CKD symptoms
- CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
- Patient's age between 25 - 60 years
- Ability to understand and willingness to sign consent from
Who cannot join
- Pregnant or lactating
- Basis disease such as diabetes, malignancy and autoimmune
- Unable to follow post-operative exercise regimen or return for evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Intravenous injection
- Keywords
- autologous bone marrow mesenchymal stem cells chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injectionBiological
Also called Intravenous transplantation
Intravenous injection of bone marrow derived MSC in patients with CKD.
| Study group | Role | What they receive |
|---|---|---|
| MSC recipient | Experimental | The patients with CKD who underwent intravenous injection of MSC. Receives: Biological: Intravenous injection |
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 due to MSC transplantation 6 months after cell injection.
Measured: 6months
Creatinin
Evaluation the rise of creatinin 1 month after cell transplantation.
Measured: 1 month
Secondary outcomes (1)
GFR
Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startApr 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.
- Other trials for Chronic Kidney DiseaseStudies 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
- 7 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 regenerative medicine department &cell therapy center of Royan InstituteAtieh Makhloogh, MD, Study director, Mazandaran University of Medical Sciences, Mazandaran, IranReza 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
- NCT02195323
- Sponsor's protocol ID
- Royan-Kidney-004
- Status last verified
- Nov 2015
- First submitted
- 17 Jul 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT02195323
- Acronym / sponsor ID
- Royan-Kidney-004
- Conditions
- Chronic Kidney Disease
- Keywords
- autologous bone marrow mesenchymal stem cells chronic kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Jul 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 kidney disease (CKD).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC recipient | Experimental | Biological: Intravenous injectionThe patients with CKD who underwent intravenous injection of MSC. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and Female
- CKD symptoms
- CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
- Patient's age between 25 - 60 years
- Ability to understand and willingness to sign consent from
Key exclusion criteria (3 listed)
- Pregnant or lactating
- Basis disease such as diabetes, malignancy and autoimmune
- Unable to follow post-operative exercise regimen or return for evaluations
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 injectionAlso: Intravenous transplantationIntravenous injection of bone marrow derived MSC in patients with CKD. | Biological | MSC recipient |
Primary outcome
mass formation
Time frame: 6months
Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Creatinin
Time frame: 1 month
Evaluation the rise of creatinin 1 month after cell transplantation.
1 secondary outcome
GFR
Time frame: 6months
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.
- 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 regenerative medicine department &cell therapy center of Royan Institute
Atieh Makhloogh, 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 in people with Chronic 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 5 inclusion and 3 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: 6months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.