Diabetic NephropathyPhase 1/2NCT01843387
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy
A Phase 1/2 study testing Mesenchymal Precursor Cells (MPCs) in people with Diabetic Nephropathy and Type 2 Diabetes, run by Mesoblast, Ltd. at 2 sites in Australia.
Trial summary
The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetic Nephropathy, Type 2 Diabetes
- What is being tested?
- Mesenchymal Precursor Cells (MPCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2013to Sep 2015
- Phase
- Phase 1/2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women who are ≥ 50 and ≤ 85 years old
- Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
- Subjects with diabetic nephropathy and CKD stage 3b-4
- Albumin-to-creatinine ratio (ACR) from a spot urine sample >30 and < 3000 mg/g at Screening
- Subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) for at least 12 weeks prior to Screening.
- HbA1c < 10.0% at Screening
Who cannot join
- Prior participation in any stem cell study
- Women of childbearing potential
- Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
- History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
- Body weight >150 kg
- Subjects with non-diabetic renal disease e.g. known polycystic kidney disease
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- Subjects with a history of a renal transplant or who have had prior dialysis within 3 months of Screening and/or have not maintained a stable level of kidney function within 3 months of Screening
- Current or history within 6 months of Screening of NYHA Class III or IV heart failure
- Myocardial infarction or stroke within 6 months prior to Screening
- Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the Investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash Universtiy
Clayton
Melbourne Renal Research Group
Melbourne
About this study
Official title: A Randomized, Controlled, Dose-Escalation Pilot Study to Assess the Safety and Efficacy of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Diabetic Nephropathy and Type 2 Diabetes
The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.
Read the detailed description
This study is taking place in Melbourne, Australia.
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes
- Being tested
- Mesenchymal Precursor Cells (MPCs)
- Keywords
- Diabetic nephropathy, Chronic kidney disease, Metabolic disease, Diabetes mellitus, type 2
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Precursor Cells (MPCs)Biological
Single Intravenous Infusion of MPCs Dose 1 or Placebo
Mesenchymal Precursor Cells (MPCs)Biological
Single Intravenous Infusion of MPCs Dose 2 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo Receives: Biological: Mesenchymal Precursor Cells (MPCs) |
| Cohort 2 | Experimental | Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo Receives: Biological: Mesenchymal Precursor Cells (MPCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess the safety and tolerability of MPC therapy
Outcomes include the following safety parameters:
- Number of and percent of subject with adverse events and serious adverse events
- Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms
- Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
Measured: 60 Weeks
Secondary outcomes (1)
Exploratory assessment of the efficacy of MPC therapy
Outcomes include changes from baseline at 12 weeks in the following parameters:
- Renal function (glomerular filtration rate, renal blood flow)
- Serum creatinine
- Urinary albumin and protein excretion
- Glycemic control
- Biomarkers
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2015
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 Diabetic NephropathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- K Segal, PhD, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843387
- Sponsor's protocol ID
- MSB-DN001
- Status last verified
- Oct 2016
- First submitted
- 23 Apr 2013
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Packham DK, Fraser IR, Kerr PG, Segal KR. Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo-controlled, Dose Escalation Study. EBioMedicine. 2016 Oct;12:263-269. doi: 10.1016/j.ebiom.2016.09.011. Epub 2016 Sep 17.
PubMed 27743903
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Dose-Escalation Pilot Study to Assess the Safety and Efficacy of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Diabetic Nephropathy and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01843387
- Acronym / sponsor ID
- MSB-DN001
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes
- Keywords
- Diabetic nephropathy, Chronic kidney disease, Metabolic disease, Diabetes mellitus, type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Apr 2013 (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.
The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.
Detailed description
This study is taking place in Melbourne, Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Mesenchymal Precursor Cells (MPCs)Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo |
| Cohort 2 | Experimental | Biological: Mesenchymal Precursor Cells (MPCs)Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women who are ≥ 50 and ≤ 85 years old
- Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
- Subjects with diabetic nephropathy and CKD stage 3b-4
- Albumin-to-creatinine ratio (ACR) from a spot urine sample >30 and < 3000 mg/g at Screening
- Subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) for at least 12 weeks prior to Screening.
Key exclusion criteria (10 listed)
- Prior participation in any stem cell study
- Women of childbearing potential
- Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
- History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
- Body weight >150 kg
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 |
|---|---|---|
| Mesenchymal Precursor Cells (MPCs)Single Intravenous Infusion of MPCs Dose 1 or Placebo | Biological | Cohort 1 |
| Mesenchymal Precursor Cells (MPCs)Single Intravenous Infusion of MPCs Dose 2 or Placebo | Biological | Cohort 2 |
Primary outcome
The primary objective of the study is to assess the safety and tolerability of MPC therapy
Time frame: 60 Weeks
Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
1 secondary outcome
Exploratory assessment of the efficacy of MPC therapy
Time frame: 12 Weeks
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 14 Oct 2016.
- Derived from this study: PubMed 27743903Packham DK, Fraser IR, Kerr PG, Segal KR. Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo-controlled, Dose Escalation Study. EBioMedicine. 2016 Oct;12:263-269. doi: 10.1016/j.ebiom.2016.09.011. Epub 2016 Sep 17.
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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.
K Segal, PhD study director
Mesoblast, Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Precursor Cells (MPCs) in people with Diabetic Nephropathy and Type 2 Diabetes, run by Mesoblast, Ltd. at 2 sites in Australia.
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 10 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary objective of the study is to assess the safety and tolerability of MPC therapy (time frame: 60 Weeks). 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 NCT01843387, 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 14 Oct 2016.