Type 1 Diabetes MellitusPhase 1/2NCT01496339
Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients
A Phase 1/2 study testing MenSCs transplantation and exogenous indulin injection daily in people with Type 1 Diabetes Mellitus, run by S-Evans Biosciences Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- MenSCs transplantation and exogenous indulin injection daily
- 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
- Jan 2012to May 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients at the age of 18 to 75.
- agreement to receive written informed consent.
- voluntary submission to the procedures of the study protocol.
- clinical diagnosis is classified to type 1 diabetes(T1DM).
- T1DM duration ≥ 1 and ≤ 20 years from the time of enrollment.
Who cannot join
- renal dysfunction, eye disease or other organ disease.
- cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- pregnancy
- mental disorders
- hepatitis C, HIV, RPR,active tuberculosis or blood diseases
- any malignancy
- any other severe diseases that could potentially influence the infusion results
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Chengjiang Li, MD
Charlie Xiang, Professor
About this study
Official title: Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes
The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.
Read the detailed description
Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- MenSCs transplantation, exogenous indulin injection daily
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenSCs transplantationBiological
1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
exogenous indulin injection dailyDrug
traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| Traditional therapy control | Active comparator | Not described Receives: Drug: exogenous indulin injection daily |
| Stem cell infusion | Experimental | Not described Receives: Biological: MenSCs transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
Measured: 1 year
Secondary outcomes (7)
The acute reaction and severity of adverse events related to the stem cell infusion procedure
Measured: 2 years
Number of severe and documented hypoglycemic events
Measured: 2 years
C-peptide release test
Measured: 3 months
The reduction in fasting blood glucose (FBG)
Measured: 1 year
The increase in basal C-peptide
Measured: 1 year
The postprandial blood glucose
Measured: 1 year
The random glucose level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S-Evans Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang University, Wenzhou Medical University, Zhenjiang First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Charile Xiang, Professor, Principal investigator, S-Evans Biosicences Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496339
- Sponsor's protocol ID
- SEB-1213-T1DM
- Status last verified
- Jun 2012
- First submitted
- 18 Dec 2011
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01496339
- Acronym / sponsor ID
- SEB-1213-T1DM
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- S-Evans Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang University, Wenzhou Medical University, Zhenjiang First People's Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 21 Dec 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.
The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.
Detailed description
Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional therapy control | Active comparator | Drug: exogenous indulin injection daily |
| Stem cell infusion | Experimental | Biological: MenSCs transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male and female patients at the age of 18 to 75.
- agreement to receive written informed consent.
- voluntary submission to the procedures of the study protocol.
- clinical diagnosis is classified to type 1 diabetes(T1DM).
- T1DM duration ≥ 1 and ≤ 20 years from the time of enrollment.
Key exclusion criteria (7 listed)
- renal dysfunction, eye disease or other organ disease.
- cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- pregnancy
- mental disorders
- hepatitis C, HIV, RPR,active tuberculosis or blood diseases
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 |
|---|---|---|
| MenSCs transplantation1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies. | Biological | Stem cell infusion |
| exogenous indulin injection dailytraditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose. | Drug | Traditional therapy control |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: 1 year
7 secondary outcomes
The acute reaction and severity of adverse events related to the stem cell infusion procedure
Time frame: 2 years
Number of severe and documented hypoglycemic events
Time frame: 2 years
C-peptide release test
Time frame: 3 months
The reduction in fasting blood glucose (FBG)
Time frame: 1 year
The increase in basal C-peptide
Time frame: 1 year
The postprandial blood glucose
Time frame: 1 year
The random glucose level
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
Charile Xiang, Professor principal investigator
S-Evans Biosicences Co.,Ltd
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 MenSCs transplantation and exogenous indulin injection daily in people with Type 1 Diabetes Mellitus, run by S-Evans Biosciences Co., Ltd. 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 5 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 7 Jun 2012. 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?
Contact Charlie Xiang, Professor (86-571-87236436, cxiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c) (time frame: 1 year). 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 7 Jun 2012.