ClinicalTrials.gov
ClinicalTrials.gov Menu

MSC and BMMNC in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01719640
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jianming Tan, Fuzhou General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 1y ]

Secondary Outcome Measures :
  1. exogenous insulin requirements [ Time Frame: 1y ]
  2. fasting hemoglucose [ Time Frame: 1y ]
  3. fasting c-peptide [ Time Frame: 1y ]
  4. The incidence and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 1y ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
China, Fujian
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jianming Tan, Professor, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01719640     History of Changes
Other Study ID Numbers: MSC-BMMNC-DM
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs