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MSC and BMMNC in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01719640
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : November 23, 2022
Information provided by (Responsible Party):
Jianming Tan, Fuzhou General Hospital

Brief 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 (BMMNCs) is an emerging therapeutic approach for DM, which showed promising outcomes with mild side effects. Infusion of BMMNCs 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: infusion of BMMSCs Drug: infusion BMMNCs Drug: insulin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cell and Bone Marrow Mononuclear Cell Infusion in Type 2 Diabetes Mellitus
Actual Study Start Date : January 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BMMSC+BMMNC
infusion of BMMSC+BMMNC and insulin injection
Drug: infusion of BMMSCs
infusion of BMMSCs

Drug: infusion BMMNCs
infusion of BMMNCs

Drug: insulin
intensive insulin care

Active Comparator: BMMNC
infusion of BMMNC and insulin injection
Drug: infusion BMMNCs
infusion of BMMNCs

Drug: insulin
intensive insulin care

Active Comparator: Insulin
insulin injection
Drug: insulin
intensive insulin care

Primary Outcome Measures :
  1. macrovascular complications [ Time Frame: 8 years ]
  2. microvascular complications [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. DPN [ Time Frame: 8 years ]
    diabetes peripheral neuropathy

  2. MI [ Time Frame: 8 years ]
    myocardial infarction

  3. angina [ Time Frame: 8 years ]

  4. stroke [ Time Frame: 8 years ]

  5. amputation [ Time Frame: 8 years ]

  6. DN [ Time Frame: 8 years ]
    diabetes nephropathy

  7. DRP [ Time Frame: 8 years ]
    diabetes retinopathy

  8. pro-DRP [ Time Frame: 8 years ]
    proliferative diabetes retinopathy

  9. C-peptide AUC [ Time Frame: 1y ]
    C-peptide area under the curve

  10. insulin AUC [ Time Frame: 1y ]
    insulin area under the curve

  11. HbA1c [ Time Frame: 1y ]
    glycated hemoglobin

  12. FBG [ Time Frame: 1y ]
    fasting hemoglucose

  13. insuline dose [ Time Frame: 1y ]
    exogenous insulin requirements

  14. fasting C-p [ Time Frame: 1y ]
    fasting c-peptide

  15. The incidence and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 8y ]

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719640

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China, Fujian
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
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Responsible Party: Jianming Tan, Professor, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01719640    
Other Study ID Numbers: MSC-BMMNC-DM
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianming Tan, Fuzhou General Hospital:
mesenchymal stem cells
bone marrow mononeclear cells
type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs