Evidence of Liver TransplantationPhase 2/3NCT01157403
Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
A Phase 2/3 study testing Autologous transplantation in people with Evidence of Liver Transplantation, run by Lu Debin at 1 site in China.
Trial summary
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Evidence of Liver Transplantation
- What is being tested?
- Autologous transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Aug 2014
- Phase
- Phase 2/3
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to provide written informed consent from patients or Child guardian
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •
Who cannot join
- Body Mass Index >30
- Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
- Presence of malignancy
Trial locations and contacts
1 site in 1 country.
Chen bing, doctor contact
lu debin, doctor contact
China1 site, 1 recruiting
- Recruiting
Endocrine Department, the south west Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038
Chen Bing, doctor, cb@mail.tmmu.com.cn
Lu Debin, doctor, ldb2005056@yahoo.COM.CN
About this study
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
Read the detailed description
Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously
- Conditions
- Evidence of Liver Transplantation
- Being tested
- Autologous transplantation
- Keywords
- mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous transplantationBiological
Also called SWH2010A19
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM. Receives: Biological: Autologous transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
C peptide release test
The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells
Measured: 6 Months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Debin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Debin, Third Military Medical University
- Investigators
- chen bing, doctor, Study director, Endocrine Department, the south west Hospital of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157403
- Sponsor's protocol ID
- ldb201001
- Status last verified
- Jun 2013
- First submitted
- 2 Jul 2010
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01157403
- Acronym / sponsor ID
- ldb201001
- Conditions
- Evidence of Liver Transplantation
- Keywords
- mesenchymal stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lu DebinUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Jul 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.
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
Detailed description
Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: Autologous transplantationTo study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ability to provide written informed consent from patients or Child guardian
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •
Key exclusion criteria (5 listed)
- Body Mass Index >30
- Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
- Presence of malignancy
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 |
|---|---|---|
| Autologous transplantationAlso: SWH2010A19Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously | Biological | mesenchymal stem cells |
Primary outcome
C peptide release test
Time frame: 6 Months after intervention
The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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.
Chen bing, doctor contact
lu debin, doctor contact
chen bing, doctor study director
Endocrine Department, the south west Hospital of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous transplantation in people with Evidence of Liver Transplantation, run by Lu Debin 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 5 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 18 Jun 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chen bing, doctor (903262619@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C peptide release test (time frame: 6 Months after intervention). 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 18 Jun 2013.