Type 2 Diabetes MellitusPhase 1/2NCT01677013
Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus
A Phase 1/2 study testing BMMCT in people with Type 2 Diabetes Mellitus, run by Peking University Aerospace Center Hospital at 1 site in China.
Trial summary
The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BMMCT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,026 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Jul 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- age 30-70
- stable doses of medication for at least 3 months
- BMI <35 and >18.5
Who cannot join
- secondary cause for hyperglycemia
- pregnancy or nursing
- positive autoimmune antibody of diabetes
- severe complication or concurrent diseases
- active infection or febrile illness
- allergy to iodine
Show all 10Show fewer
- history or signs of aortic aneurysm
- history or active pancreatic diseases
- known substance abuse or alcoholism or heavy smoking
- not suitable for other conditions upon investigators' expertise
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
Beijing, Beijing Municipality, 100049
About this study
Official title: Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
Read the detailed description
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BMMCT
- Keywords
- Type 2; diabetes mellitus; stem cell; safety; efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMMCTOther
Also called Bone marrow mononuclear cell transplantation
Bone marrow mononuclear cell transplantation via selective catheterization
| Study group | Role | What they receive |
|---|---|---|
| Oral medication treatment | No intervention | type 2 diabetics with only oral medications |
| Oral medication plus BMMCT | Experimental | Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. Receives: Other: BMMCT |
| Oral medication plus insulin treatment | No intervention | Type 2 diabetics who need insulin therapy with oral medications |
| Oral medication plus insulin plus BMMCT | Experimental | Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. Receives: Other: BMMCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide
Measured: 1 year
Secondary outcomes (3)
reduction of medication
Measured: 1 year
HbA1c
Measured: 1 year
adverse event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Lei, MD, Peking University Aerospace Center Hospital
- Investigators
- Yizhong Wang, M.D., Ph.D., Study chair, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalYuanjie Mao, M.D., Ph.D., Study director, Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship HospitalLei Lei, M.D., Principal investigator, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalDanping Meng, M.D., Principal investigator, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalXiyang Zhang, M.D., Principal investigator, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalXiaolin Jia, M.D., Study director, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalQiuming Jiang, M.D., Principal investigator, Division of Hematology and Endocrinology, Peking University Aerospace Centre HospitalYufang Li, M.D., Principal investigator, Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677013
- Sponsor's protocol ID
- PUACH-721002
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2012
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01677013
- Acronym / sponsor ID
- PUACH-721002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2; diabetes mellitus; stem cell; safety; efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- Peking University Aerospace Center HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Aug 2012 (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 study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
Detailed description
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral medication treatment | No intervention | –type 2 diabetics with only oral medications |
| Oral medication plus BMMCT | Experimental | Other: BMMCTCollect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. |
| Oral medication plus insulin treatment | No intervention | –Type 2 diabetics who need insulin therapy with oral medications |
| Oral medication plus insulin plus BMMCT | Experimental | Other: BMMCTCollect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus
- age 30-70
- stable doses of medication for at least 3 months
- BMI <35 and >18.5
Key exclusion criteria (10 listed)
- secondary cause for hyperglycemia
- pregnancy or nursing
- positive autoimmune antibody of diabetes
- severe complication or concurrent diseases
- active infection or febrile illness
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 |
|---|---|---|
| BMMCTAlso: Bone marrow mononuclear cell transplantationBone marrow mononuclear cell transplantation via selective catheterization | Other | Oral medication plus BMMCT, Oral medication plus insulin plus BMMCT |
Primary outcome
C-peptide
Time frame: 1 year
3 secondary outcomes
reduction of medication
Time frame: 1 year
HbA1c
Time frame: 1 year
adverse event
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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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.
Yizhong Wang, M.D., Ph.D. study chair
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
Yuanjie Mao, M.D., Ph.D. study director
Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital
Lei Lei, M.D. principal investigator
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
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 BMMCT in people with Type 2 Diabetes Mellitus, run by Peking University Aerospace Center Hospital 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 3 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (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 3 Oct 2017.