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Diabetes Mellitus, Type 2Phase 1/2NCT01719640

MSC and MC in Type 2 Diabetes Mellitus

A Phase 1/2 study testing infusion of MSCs, infusion MCs and insulin in people with Diabetes Mellitus, Type 2, run by Fuzhou General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear cells (MCs) is an emerging therapeutic approach for DM, which showed promising outcomes with mild side effects. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
infusion of MSCs, infusion MCs and insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
Jan 2011to Jan 2020
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent.
  • Mentally stable and able to comply with the procedures of the study protocol.
  • Clinical history compatible with type 2 diabetes (T2DM) as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus
  • Onset of T2DM disease at ≥ 35 years of age.
  • T2DM duration ≥ 3 and ≤ 20 years at the time of enrollment.
  • Basal C-peptide 0.3-2.0 ng/mL
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  • HbA1c ≥ 7.5 and ≤ 12% before standard medical therapy (SMT). Patients must have been treated with SMT for minimum of 4 months prior to randomization.
  • Insulin dose and metformin doses should be stable over the 3 months prior to randomization.
  • HbA1c ≥ 7.5 and ≤ 9.5% at time of randomization.
  • Total insulin daily dose (TDD) at time of randomization should not exceed 1.0 units/day/kg

Who cannot join

  • BMI >35 kg/m2.
  • Insulin requirements of > 100 U/day.
  • HbA1c >9.5%. (at the time of randomization)
  • C-reactive protein (hs-CRP) >3.00
  • Uncontrolled blood Pressure: SBP >160 mmHg or DBP >100 mmHg at the time of randomization.
  • Evidence of renal dysfunction, serum creatinine > 1.5 mg/dl (males) and 1.4 mg/dl (females).
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  • Proteinuria > 300 mg/day
  • Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
  • For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception. Oral contraceptives,Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable
  • Active infection including hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation
  • Known active alcohol or substance abuse including cigarette/cigar smoking
  • Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/L), neutropenia (<1,500/L), or thrombocytopenia (platelets <100,000/L).
  • A history of Factor V deficiency or other coagulopathy defined by INR >1.5, PTT>40, PT >15.
  • Any coagulopathy or medical condition requiring long-term anticoagulant therapy(e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an INR >1.5.
  • Acute or chronic pancreatitis.
  • Symptomatic peptic ulcer disease.
  • Hyperlipidemia despite medical therapy (fasting LDL cholesterol >130 mg/dl, treated or untreated; and/or fasting triglycerides > 200 mg/dl).
  • Receiving treatment for a medical condition requiring chronic use of systemic steroids.
  • Symptomatic cholecystolithiasis.
  • Use of any investigational agents within 4 weeks of enrollment.
  • Admission to hospital for any reason in the 14 days prior to enrollment (signing consent).
  • Presence of active proliferative diabetic retinopathy or macular edema
  • Any malignancy
  • Abnormal liver function >1.5 x ULN
  • Abdominal aortic aneurysm
  • History of cerebro-vascular accident
  • Any patient with acute or subacute decompensation from diabetes
  • Any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient.
  • Subjects with hypoproteinemia, cachexia or terminal states
  • Subjects with history of anorexia/bulimia
  • Subjects with respiratory insufficiency
  • Subjects that are being treated with any medication that could interfere with the outcome of the study such as: Sulfonylureas, Thiazolidinediones and glucagon like peptide 1 (GLP-1) analogues (Exenatide, Byetta), Pramlintide (Amylin), Dipeptidylpeptidase IV (DPP-IV) inhibitors (i.e. Sitagliptin, Januvia)
  • Any medical condition that, in the opinion of the investigator, will interfere with thesafe completion of the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuzhou General Hospital, Xiamen Univ

    Fuzhou, Fujian, 350025

Other trials in China

About this study

Official title: Autologous Bone Marrow Mesenchymal Stem Cell and Bone Marrow Mononuclear Cell Infusion in Type 2 Diabetes Mellitus

Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear cells (MCs) is an emerging therapeutic approach for DM, which showed promising outcomes with mild side effects. Infusion of MCs and autologous bone marrow mesenchymal stem cells in combination might exert enhanced repairing effects. We hypothesized that infusion of these two classes of cells might provide multiple signals for regeneration and improve recovery from inflammation-induced lesion. The effects might be maximized by intra-arterial pancreatic infusion.

Being tested
infusion of MSCs, infusion MCs, insulin
Keywords
mesenchymal stem cells, bone marrow mononeclear cells, type 2 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infusion of MSCsDrug

    infusion of MSCs

  • infusion MCsDrug

    infusion of MCs

  • insulinDrug

    intensive insulin care

Study groups in NCT01719640
Study groupRoleWhat they receive
MSC+MCExperimentalinfusion of BMMSC+BMMNC and insulin injection
Receives: Drug: infusion of MSCs; Drug: infusion MCs; Drug: insulin
MCActive comparatorinfusion of BMMNC and insulin injection
Receives: Drug: infusion MCs; Drug: insulin
InsulinActive comparatorinsulin injection
Receives: Drug: insulin

What is being measured

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

  1. macrovascular complications

    Measured: 8 years

  2. microvascular complications

    Measured: 8 years

Secondary outcomes (15)

  1. DPN

    diabetes peripheral neuropathy

    Measured: 8 years

  2. MI

    myocardial infarction

    Measured: 8 years

  3. angina

    angina

    Measured: 8 years

  4. stroke

    stroke

    Measured: 8 years

  5. amputation

    amputation

    Measured: 8 years

  6. DN

    diabetes nephropathy

    Measured: 8 years

  7. DRP

    diabetes retinopathy

    Measured: 8 years

  8. pro-DRP

    proliferative diabetes retinopathy

    Measured: 8 years

  9. C-peptide AUC

    C-peptide area under the curve

    Measured: 1y

  10. insulin AUC

    insulin area under the curve

    Measured: 1y

  11. HbA1c

    glycated hemoglobin

    Measured: 1y

  12. FBG

    fasting hemoglucose

    Measured: 1y

  13. insuline dose

    exogenous insulin requirements

    Measured: 1y

  14. fasting C-p

    fasting c-peptide

    Measured: 1y

  15. The incidence and severity of adverse events related to the stem cell infusion procedure

    Measured: 8y

Timeline

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

  1. First posted1 Nov 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionJan 2020

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719640
Sponsor's protocol ID
MSC-MC-DM
Status last verified
Jan 2023
First submitted
6 Oct 2012
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu Z, Huang S, Li S, Cai J, Huang L, Wu W, Chen J, Tan J. Bone marrow mesenchymal stem cell and mononuclear cell combination therapy in patients with type 2 diabetes mellitus: a randomized controlled study with 8-year follow-up. Stem Cell Res Ther. 2024 Sep 30;15(1):339. doi: 10.1186/s13287-024-03907-w.

    PubMed 39350270

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing infusion of MSCs, infusion MCs and insulin in people with Diabetes Mellitus, Type 2, run by Fuzhou General 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 10 inclusion and 33 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 12 Jan 2023. 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?

macrovascular complications (time frame: 8 years). The study lists 2 primary outcomes in all. 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 NCT01719640, 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 12 Jan 2023.

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