This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

UCMSC and BMMNC in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT01719640
First received: October 6, 2012
Last updated: September 20, 2017
Last verified: September 2017
  Purpose
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 umbilical cord 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 Intervention Phase
Diabetes Mellitus, Type 2 Drug: infusion of UCMSCs Drug: infusion BMMNCs Drug: insulin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cell and Autologous Bone Marrow Mononuclear Cell Infusion in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

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

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

Enrollment: 30
Actual Study Start Date: January 2011
Study Completion Date: January 2017
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UCMSC+BMMNC
infusion of UCMSC+BMMNC at day 0, 7, 14 and 21 and insulin injection
Drug: infusion of UCMSCs
infusion of aUCMSCs at day 0, 7,14 and 21
Drug: infusion BMMNCs
infusion of BMMNCs at day 0, 7,14 and 21
Drug: insulin
intensive insulin care
Active Comparator: BMMNC
infusion of BMMNC at day 0, 7, 14 and 21 and insulin injection
Drug: infusion BMMNCs
infusion of BMMNCs at day 0, 7,14 and 21
Drug: insulin
intensive insulin care
Active Comparator: Insulin
insulin injection
Drug: insulin
intensive insulin care

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (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

    - Page 5 of 5 -

  • Subjects with a history of chronic sinusitis (sinusitis lasting more than 8 weeks in the past year) or recurrent acute sinusitis (sinusitis lasting more than 4 weeks more than four times in the past year.
  • Any contraindication to hyperbaric oxygen treatment
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719640

Locations
China, Fujian
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
  More Information

Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01719640     History of Changes
Other Study ID Numbers: MSC-BMMNC-DM
Study First Received: October 6, 2012
Last Updated: September 20, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fuzhou General Hospital:
umbilical cord 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

ClinicalTrials.gov processed this record on September 21, 2017