Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT01374854
First received: June 15, 2011
Last updated: November 18, 2012
Last verified: November 2012
  Purpose

Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration therapy with mild side effect as indicated by large quantities of animal experiments and some clinical trials. There are few UC-MSCs clinical trials with regard to diabetes mellitus. The investigators hypothesize that infusion of USC-MSCs may provide multiple signals for beta-cell regeneration and even re-differentiate into local tissues in diabetes mellitus patients, resulting in improvement of diabetic control, of which the effect may be promoted by concomitant infusion of bone marrow mononuclear cells and maximized by intra-arterial pancreatic infusion through angiography.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Biological: Umbilical mesenchymal stem cell (UC-MSCs) infusion
Drug: traditional therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus: A Randomized Controlled Open-label Study

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • c-peptide area under the curve during OGTT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The increase in basal C-peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The reduction in exogenous insulin requirements [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Decrease in HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • insulin area under the curve during OGTT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell Infusion Biological: Umbilical mesenchymal stem cell (UC-MSCs) infusion
1×10^6/kg UC-MSCs is infused through pancreatic artery along with mononuclear cells by interventional therapy and another same dose of UC-MSCs is administered one week post-intervention.
Active Comparator: traditional therapy control Drug: traditional therapy
exogenous insulin injection daily

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients age 18 to 65 years of age.
  • Ability to provide written informed consent.
  • Mentally stable and able to comply with the procedures of the study protocol.
  • Clinical history compatible with type 1 diabetes (T1DM) as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus
  • Onset of T1DM disease at ≤ 35 years of age.
  • T1DM duration ≥ 2 and ≤ 20 years at the time of enrollment.
  • Basal C-peptide ≤ 0.3 ng/mL
  • HbA1c ≥ 7.5 at time of enrollment.

Exclusion Criteria:

  • BMI >35 kg/m^2.
  • Insulin requirements of > 100 U/day.
  • C-reactive protein (hs-CRP) >3.00ng/ml
  • Uncontrolled blood Pressure: SBP >160 mmHg or DBP >100 mmHg at the time of enrollment.
  • 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 Hemoglobin 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
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe 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: NCT01374854

Locations
China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
  More Information

No publications provided

Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01374854     History of Changes
Other Study ID Numbers: UCMSC-T1DM
Study First Received: June 15, 2011
Last Updated: November 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fuzhou General Hospital:
type 1 diabetes mellitus
umbilical mesenchymal stem cell
mononuclear cell

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014