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Type 2 Diabetes MellitusPhase 1NCT01142050

Stem Cell Therapy for Type 2 Diabetes Mellitus

A Phase 1 study testing mesenchymal stem cells in people with Type 2 Diabetes Mellitus, run by Cellonis Biotechnology Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
mesenchymal stem cells
Type of treatment
Injection or infusion
How many people
24 participants
Where
1 siteChina
Study dates
Aug 2010to Dec 2011
Phase
Phase 1
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

  • Free will taking part in the study and ability to provide written informed consent;
  • Type 2 diabetes mellitus (as guideline WHO, 1999);
  • Age 18-75 years old，Male/Female;
  • 19≤Body mass index (BMI)≤30㎏/㎡;
  • Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
  • Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
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  • Not pregnant or nursing;
  • Negative pregnancy test;
  • Fertile patients will use effective contraception.

Who cannot join

  • Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
  • Active infection requiring treatment;
  • Unexplained febrile illness;
  • Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Armed Police General Hospital, P.R. China

    Beijing, 100085

    Shi X Y, M.D.

Other trials in China

About this study

Official title: A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus

The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

Read the detailed description
  • To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
  • To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.
Being tested
mesenchymal stem cells
Keywords
stem cells;, diabetes mellitus;, treatment.
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.

  • mesenchymal stem cellsBiological

    1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;

    1. Insulin resistance index indicated by ITT change compared with baseline.
    2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.
    3. Hemoglobin A1c.
    4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG).
    5. C-peptide levels.
    6. Serum Insulin levels.

    Measured: one year

Secondary outcomes (1)

  1. Serious adverse event frequency and severity

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01142050
Sponsor's protocol ID
Cellonis-CR-2.3
Status last verified
Jun 2010
First submitted
10 Jun 2010
Last updated
11 Jun 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mesenchymal stem cells in people with Type 2 Diabetes Mellitus, run by Cellonis Biotechnology 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 9 inclusion and 4 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 11 Jun 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 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.

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?

ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; (time frame: one year). 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 NCT01142050.

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 11 Jun 2010.

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Stem Cell Therapy for Type 2 Diabetes Mellitus | AzTrials