Diabetes MellitusPhase 1/2NCT01219465
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective. Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Mesenchymal Stem Cells
- What is being tested?
- umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2012
- 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 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
- Ability to provide written informed consent from patients or Child guardian.
Who cannot join
- diabetic ketoacidosis.
- evidence of retinopathy at baseline.
- Body Mass Index >30.
- Severe or acute organ damage.
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
- Severe psychiatric disorder.
- Presence of malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.
Read the detailed description
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.
- Being tested
- umbilical cord mesenchymal stem cells
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
Also called mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells Receives: Biological: umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
C peptide release test
Measured: 3 months
Secondary outcomes (5)
Exogenous insulin dose
Measured: 3 months
blood glucose
Measured: 3 months
glycosylated Hemoglobin A1c
Measured: 3 months
Number of severe and documented hypoglycemic events
Measured: 3 months
Immunologic reconstitution parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Investigators
- Yangang Wang, MD Phd, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219465
- Sponsor's protocol ID
- MSCT1DM003
- Status last verified
- Sep 2010
- First submitted
- 12 Oct 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01219465
- Acronym / sponsor ID
- MSCT1DM003
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Oct 2010 (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 determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.
Detailed description
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Biological: umbilical cord mesenchymal stem cellsIntravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
- Ability to provide written informed consent from patients or Child guardian.
Key exclusion criteria (7 listed)
- diabetic ketoacidosis.
- evidence of retinopathy at baseline.
- Body Mass Index >30.
- Severe or acute organ damage.
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
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 |
|---|---|---|
| umbilical cord mesenchymal stem cellsAlso: mesenchymal stem cellsTransfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously. | Biological | umbilical cord mesenchymal stem cells |
Primary outcome
C peptide release test
Time frame: 3 months
5 secondary outcomes
Exogenous insulin dose
Time frame: 3 months
blood glucose
Time frame: 3 months
glycosylated Hemoglobin A1c
Time frame: 3 months
Number of severe and documented hypoglycemic events
Time frame: 3 months
Immunologic reconstitution parameters
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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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.
Yangang Wang, MD Phd study director
The Affiliated Hospital of Qingdao University
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 umbilical cord mesenchymal stem cells in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Qingdao University at 1 site in China.
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 7 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 13 Oct 2010. 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 China. 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?
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?
C peptide release test (time frame: 3 months). 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 13 Oct 2010.