Type 1 Diabetes MellitusPhase 2DMT1-MSCNCT02893306
MSC Administration for the Management of Type 1 Diabetic Patients
A Phase 2 study testing MSCs in people with Type 1 Diabetes Mellitus, run by Universidad del Desarrollo at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- Mar 2012to Mar 2017
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- differential diagnosis of Type 1 Diabetes
- diagnosed performed at most 1 year before enrollment
- pancreatic reserve of insulin higher than 0.8 nmol/L/h
- good general health status
- informed consent of patient
- consent of treating physician
- proved psychiatric competence to be enrolled in a clinical study
Who cannot join
- pregnancy
- significant comorbidities
- HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.
Read the detailed description
Aim: to evaluate whether a single intravenous administration of allogeneic bone marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified endogenous insulin secretion capacity and exogenous insulin requirement in patients with Type 1 Diabetes Mellitus.
Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with pancreatic reserve of insulin.
Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic MSCs.
Follow up: before and 1, 6, 24 months after MSC administration.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- MSCs
- Keywords
- Type1 Diabetes Mellitus, Multipotent stromal cell, Mesenchymal stem cell, Insulin, Pancreatic reserve, Disease progression
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCsBiological
Also called mesenchymal stem cells
origin: bone marrow of healthy donor; manipulation: ex vivo expanded; via: intravenous; vehicle: 5% human recombinant albumin in physiological serum; dose: 2-3 millions/Kg; dosage: single
| Study group | Role | What they receive |
|---|---|---|
| DMT1+MSCs | Experimental | type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells Receives: Biological: MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin pancreatic reserve
Levels of insulin secreted after the acute ingestion of a protein rich liquid diet
Measured: pre- and 1, 6, 24 months post-intervention
Secondary outcomes (1)
Changes in insulin requirement
Daily dose of self-administered insulin
Measured: pre- and up to 24 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startMar 2012
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Alemana de Santiago
- Responsible party
- Principal investigator, Paulette Conget, Universidad del Desarrollo
- Investigators
- Paulette Conget, PhD, Principal investigator, Universidad del DesarrolloClaudio Mizon, MD, Principal investigator, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893306
- Sponsor's protocol ID
- DMT1-MSC
- Acronym
- DMT1-MSC
- Status last verified
- Sep 2016
- First submitted
- 27 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be publish in a peer review journal
Publications
Ezquer F, Ezquer M, Contador D, Ricca M, Simon V, Conget P. The antidiabetic effect of mesenchymal stem cells is unrelated to their transdifferentiation potential but to their capability to restore Th1/Th2 balance and to modify the pancreatic microenvironment. Stem Cells. 2012 Aug;30(8):1664-74. doi: 10.1002/stem.1132.
PubMed 22644660Ezquer F, Ezquer M, Simon V, Conget P. The antidiabetic effect of MSCs is not impaired by insulin prophylaxis and is not improved by a second dose of cells. PLoS One. 2011 Jan 27;6(1):e16566. doi: 10.1371/journal.pone.0016566.
PubMed 21304603Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.
PubMed 18489988
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT02893306
- Acronym / sponsor ID
- DMT1-MSC / DMT1-MSC
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type1 Diabetes Mellitus, Multipotent stromal cell, Mesenchymal stem cell, Insulin, Pancreatic reserve, Disease progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Clinica Alemana de Santiago
- Study start
- Mar 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 8 Sep 2016 (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 purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.
Detailed description
Aim: to evaluate whether a single intravenous administration of allogeneic bone marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified endogenous insulin secretion capacity and exogenous insulin requirement in patients with Type 1 Diabetes Mellitus.
Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with pancreatic reserve of insulin.
Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic MSCs.
Follow up: before and 1, 6, 24 months after MSC administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMT1+MSCs | Experimental | Biological: MSCstype 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- differential diagnosis of Type 1 Diabetes
- diagnosed performed at most 1 year before enrollment
- pancreatic reserve of insulin higher than 0.8 nmol/L/h
- good general health status
- informed consent of patient
Key exclusion criteria (3 listed)
- pregnancy
- significant comorbidities
- HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive
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 |
|---|---|---|
| MSCsAlso: mesenchymal stem cellsorigin: bone marrow of healthy donor; manipulation: ex vivo expanded; via: intravenous; vehicle: 5% human recombinant albumin in physiological serum; dose: 2-3 millions/Kg; dosage: single | Biological | DMT1+MSCs |
Primary outcome
Changes in insulin pancreatic reserve
Time frame: pre- and 1, 6, 24 months post-intervention
Levels of insulin secreted after the acute ingestion of a protein rich liquid diet
1 secondary outcome
Changes in insulin requirement
Time frame: pre- and up to 24 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 22644660Ezquer F, Ezquer M, Contador D, Ricca M, Simon V, Conget P. The antidiabetic effect of mesenchymal stem cells is unrelated to their transdifferentiation potential but to their capability to restore Th1/Th2 balance and to modify the pancreatic microenvironment. Stem Cells. 2012 Aug;30(8):1664-74. doi: 10.1002/stem.1132.
- Background: PubMed 21304603Ezquer F, Ezquer M, Simon V, Conget P. The antidiabetic effect of MSCs is not impaired by insulin prophylaxis and is not improved by a second dose of cells. PLoS One. 2011 Jan 27;6(1):e16566. doi: 10.1371/journal.pone.0016566.
- Background: PubMed 18489988Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.
- Individual participant dataSharing planned: Yes. Data will be publish in a peer review journal
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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.
Paulette Conget, PhD principal investigator
Universidad del Desarrollo
Claudio Mizon, MD principal investigator
Clinica Alemana de Santiago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSCs in people with Type 1 Diabetes Mellitus, run by Universidad del Desarrollo at 1 site in Chile.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Sep 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 Chile. 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 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?
Results are not available in the source record.
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?
Changes in insulin pancreatic reserve (time frame: pre- and 1, 6, 24 months post-intervention). 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 NCT02893306, which also lists 3 linked publications.
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 8 Sep 2016.