Ketoacidosis, DiabeticPhase 2UCMSCDKANCT02763423
Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis
A Phase 2 study testing umbilical cord mesenchymal stem cell in people with Ketoacidosis, Diabetic, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Ketoacidosis, Diabetic
- What is being tested?
- umbilical cord mesenchymal stem cell
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2019
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes
- Duration of disease less than 12 months from diagnosis
- With the history of diabetic ketoacidosis
Who cannot join
- 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.
China1 site, 1 recruiting
- Recruiting
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Dalong Zhu, MD.PhD., 86-25-83106666 ext. 61430, zhudalong@nju.edu.cn
Jing Lu, PhD., 86-25-83106666 ext. 61431, qiusnow16@hotmail.com
About this study
Official title: The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.
Read the detailed description
To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
- Conditions
- Ketoacidosis, Diabetic
- Being tested
- umbilical cord mesenchymal stem cell
- Keywords
- umbilical cord stem cell, diabetic ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellProcedure or surgery
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cell | Experimental | single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients Receives: Procedure: umbilical cord mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline exogenous insulin dose at different time points post treatment
Measured: 1 month, 3 months,6 months, 12 months, 24 months, 36 months
Secondary outcomes (3)
C-peptide level
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
HbA1c level
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
titres of islet antigen antibodies
Measured: 1 month, 3 months, 6 months, 12 months,24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ketoacidosis, DiabeticStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Dalong Zhu, MD.PhD., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763423
- Sponsor's protocol ID
- NJGYNFM-SC-02
- Acronym
- UCMSCDKA
- Status last verified
- May 2016
- First submitted
- 19 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1.
PubMed 35941696
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT02763423
- Acronym / sponsor ID
- UCMSCDKA / NJGYNFM-SC-02
- Conditions
- Ketoacidosis, Diabetic
- Keywords
- umbilical cord stem cell, diabetic ketoacidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 May 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.
This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.
Detailed description
To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord mesenchymal stem cell | Experimental | Procedure: umbilical cord mesenchymal stem cellsingle- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Duration of disease less than 12 months from diagnosis
- With the history of diabetic ketoacidosis
Key exclusion criteria (5 listed)
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment(renal,hepatic,cardiac,pulmonary)
- Active infectious disease
- Previous or present neoplastic 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 |
|---|---|---|
| umbilical cord mesenchymal stem cellallogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection | Procedure or surgery | umbilical cord mesenchymal stem cell |
Primary outcome
Changes from baseline exogenous insulin dose at different time points post treatment
Time frame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months
3 secondary outcomes
C-peptide level
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
HbA1c level
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
titres of islet antigen antibodies
Time frame: 1 month, 3 months, 6 months, 12 months,24 months, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 35941696Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1.
- Individual participant dataSharing planned: No
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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.
Dalong Zhu, MD.PhD. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 umbilical cord mesenchymal stem cell in people with Ketoacidosis, Diabetic, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 3 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 5 May 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 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 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?
Contact Dalong Zhu, MD.PhD. (86-25-83106666 ext. 61430, zhudalong@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline exogenous insulin dose at different time points post treatment (time frame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months). 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 NCT02763423, which also lists 1 linked publication.
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 5 May 2016.