Diabetes Mellitus, Insulin-DependentPhase 1/2NCT01322789
Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
A Phase 1/2 study testing Intravenous Mesenchymal stem cell infusion in people with Diabetes Mellitus, Insulin-Dependent, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- Intravenous Mesenchymal stem cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Dec 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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
- Less than 6 weeks from diagnosis
Who cannot join
- Previous diabetic ketoacidosis
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment (renal, hepatic, cardiac, pulmonary)
- Active infectious disease
- Previous or present neoplastic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo
Julio C Voltarelli, MD, PhD, +551621019369, jcvoltar@fmrp.usp.br
Carlos E Couri, MD, PhD, +551691495151, ce.couri@yahoo.com.br
About this study
Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.
Read the detailed description
Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- Intravenous Mesenchymal stem cell infusion
- Keywords
- Diabetes mellitus, Stem cells, Autologous stem cell transplantation, Autoimmune diseases
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Mesenchymal stem cell infusionBiological
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
| Study group | Role | What they receive |
|---|---|---|
| Intravenous mesenchymal stem cell | Experimental | This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart Receives: Biological: Intravenous Mesenchymal stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC C-peptide levels during mixed meal tolerance test
Measured: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)
Safety
The process of analyzing safety data is made daily based on clinical interview, frequent physical examination and general laboratory findings weekly from the first stem cell infusion until 60 months after the last infusion. Chest X-ray will be performed in days 100, 180, 270, 360 after the lest infusion and then every 6 months. Fecal occult blood, alpha pheto protein, beta-human chorionic gonadotropin, carcino-embrionary antigen, abdomen ultrasound will be performed in month 6 and 12 after the last infusion and then yearly.
Measured: Every 6 months until death
Secondary outcomes (4)
Daily insulin use
Measured: Daily (course of study is 7 years)
Hemoglobin A1C
Measured: 3 months
Anti-GAD titres
Measured: Every 6 months
Immunologic reconstitution parameters
Measured: Yearly (course of study is 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startSep 2008
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Julio Voltarelli, MD, PhD, Principal investigator, University Hospital, School of Medicine of Ribeirão Preto, BrazilCarlos E Couri, MD, PhD, Study chair, University Hospital, School of Medicine of Ribeirão Preto, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322789
- Sponsor's protocol ID
- HCFMRPUSP 2
- Other IDs
- CNPQ 552266/2005-1
- Status last verified
- Nov 2010
- First submitted
- 7 Dec 2010
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01322789
- Acronym / sponsor ID
- HCFMRPUSP 2
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- Diabetes mellitus, Stem cells, Autologous stem cell transplantation, Autoimmune diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Mar 2011 (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.
Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.
Detailed description
Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous mesenchymal stem cell | Experimental | Biological: Intravenous Mesenchymal stem cell infusionThis group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
- Less than 6 weeks from diagnosis
Key exclusion criteria (6 listed)
- Previous diabetic ketoacidosis
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment (renal, hepatic, cardiac, pulmonary)
- Active infectious disease
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 Mesenchymal stem cell infusionFour consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart | Biological | Intravenous mesenchymal stem cell |
Primary outcome
AUC C-peptide levels during mixed meal tolerance test
Time frame: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)
Safety
Time frame: Every 6 months until death
The process of analyzing safety data is made daily based on clinical interview, frequent physical examination and general laboratory findings weekly from the first stem cell infusion until 60 months after the last infusion. Chest X-ray will be performed in days 100, 180, 270, 360 after the lest infusion and then every 6 months. Fecal occult blood, alpha pheto protein, beta-human chorionic gonadotropin, carcino-embrionary antigen, abdomen ultrasound will be performed in month 6 and 12 after the last infusion and then yearly.
4 secondary outcomes
Daily insulin use
Time frame: Daily (course of study is 7 years)
Hemoglobin A1C
Time frame: 3 months
Anti-GAD titres
Time frame: Every 6 months
Immunologic reconstitution parameters
Time frame: Yearly (course of study is 7 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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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.
Julio Voltarelli, MD, PhD principal investigator
University Hospital, School of Medicine of Ribeirão Preto, Brazil
Carlos E Couri, MD, PhD study chair
University Hospital, School of Medicine of Ribeirão Preto, Brazil
1 site 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 Intravenous Mesenchymal stem cell infusion in people with Diabetes Mellitus, Insulin-Dependent, run by University of Sao Paulo at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Mar 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio Voltarelli, MD, PhD (+55 16 2101 9369, jcvoltar@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC C-peptide levels during mixed meal tolerance test (time frame: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)). 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 25 Mar 2011.