Type 2 DiabetesPhase 1/2NCT01576328
Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
A Phase 1/2 study testing Mesenchymal Precursor Cells (MPCs) in people with Type 2 Diabetes, run by Mesoblast, Ltd. at 18 sites in United States.
Trial summary
This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 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
- 61 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2012to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects who are ≥ 18 and ≤ 80 years old
- Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin > 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose > 1000 mg/day documented in the subject's history
- HbA1c > 7.0% and < 10.5% at Screening
- C-peptide > 0.8 ng/mL at Screening
- Body mass index (BMI) > 22 and < 45 kg/m2 at Screening
- Body weight < 150 kg at Screening
Who cannot join
- Prior participation in any stem cell study
- Women who are pregnant, intending to become pregnant during the study period or currently lactating
- History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverage. Current cigarette smoking > 10 cigarettes per day
- Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (> 2 episodes/week) within one month prior to Screening
- Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for < 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
- Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Big Sky Clinical Research
Butte, Montana, 59701
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Providence Health Partners - Center for Clinical Reseach
Dayton, Ohio, 45439
SC Clinical Research
Garden Grove, California, 92844
Desert Endocrinology Clinical Research Center-Henderson
Henderson, Nevada, 89052
West Houston Clinical Research Services
Houston, Texas, 77055
Alliance Against Diabetes/AAD Clinical Research
Las Vegas, Nevada, 89101
Diabetes Research Institute
Miami, Florida, 33136
Tulane University Medical Center
New Orleans, Louisiana, 70112
Active Practices and Research
Newington, New Hampshire, 03801
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, 23502
Capital Clinical Research Center
Olympia, Washington, 98502
Compass Research
Orlando, Florida, 32806
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Paragon Research Center
San Antonio, Texas, 78205
About this study
Official title: A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin
This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
- Conditions
- Type 2 Diabetes
- Being tested
- Mesenchymal Precursor Cells (MPCs)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Precursor Cells (MPCs)Drug
Single intravenous infusion of MPCs Dose 1
Mesenchymal Precursor Cells (MPCs)Drug
Single intravenous infusion of MPCs Dose 2
Mesenchymal Precursor Cells (MPCs)Drug
Single intravenous infusion of MPCs Dose 3
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | MPC dose 1 or Placebo Receives: Drug: Mesenchymal Precursor Cells (MPCs) |
| Cohort 2 | Experimental | MPC dose 2 or Placebo Receives: Drug: Mesenchymal Precursor Cells (MPCs) |
| Cohort 3 | Experimental | MPC dose 3 or Placebo Receives: Drug: Mesenchymal Precursor Cells (MPCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective of the study is to assess the safety and tolerability of MPC therapy
Outcomes include the measurement of the following safety parameters:
- Adverse events and serious adverse events(including hypoglycemia)
- Vital signs (BP, HR, RR, O2 saturation)
- Physical examinations
- Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis)
- Pulmonary function test
- Electrocardiograms
- Chest X-ray
- Fundus oculi examination
Measured: 116 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 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 Type 2 DiabetesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 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
- NCT01576328
- Sponsor's protocol ID
- MSB-DM003
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2012
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.
PubMed 26153271
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin
- ClinicalTrials.gov ID
- NCT01576328
- Acronym / sponsor ID
- MSB-DM003
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Apr 2012 (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 is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Mesenchymal Precursor Cells (MPCs)MPC dose 1 or Placebo |
| Cohort 2 | Experimental | Drug: Mesenchymal Precursor Cells (MPCs)MPC dose 2 or Placebo |
| Cohort 3 | Experimental | Drug: Mesenchymal Precursor Cells (MPCs)MPC dose 3 or Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects who are ≥ 18 and ≤ 80 years old
- Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin > 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose > 1000 mg/day documented in the subject's history
- HbA1c > 7.0% and < 10.5% at Screening
- C-peptide > 0.8 ng/mL at Screening
- Body mass index (BMI) > 22 and < 45 kg/m2 at Screening
Key exclusion criteria (6 listed)
- Prior participation in any stem cell study
- Women who are pregnant, intending to become pregnant during the study period or currently lactating
- History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverage. Current cigarette smoking > 10 cigarettes per day
- Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (> 2 episodes/week) within one month prior to Screening
- Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for < 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
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 | Drug | Cohort 1 |
| Mesenchymal Precursor Cells (MPCs)Single intravenous infusion of MPCs Dose 2 | Drug | Cohort 2 |
| Mesenchymal Precursor Cells (MPCs)Single intravenous infusion of MPCs Dose 3 | Drug | Cohort 3 |
Primary outcome
Primary objective of the study is to assess the safety and tolerability of MPC therapy
Time frame: 116 Weeks
Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination
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 2 Jun 2020.
- Derived from this study: PubMed 26153271Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.
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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.
18 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 Type 2 Diabetes, run by Mesoblast, Ltd. at 18 sites in United States.
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 6 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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?
Primary objective of the study is to assess the safety and tolerability of MPC therapy (time frame: 116 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 NCT01576328, 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 2 Jun 2020.