Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01374854|
Recruitment Status : Unknown
Verified November 2012 by Fuzhou General Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 16, 2011
Last Update Posted : November 20, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: Umbilical mesenchymal stem cell (UC-MSCs) infusion Drug: traditional therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus: A Randomized Controlled Open-label Study|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2014|
|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
- c-peptide area under the curve during OGTT [ Time Frame: 1 year ]
- The incidence and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 1 year ]
- The reduction in fasting blood glucose (FBG) [ Time Frame: 1 year ]
- The increase in basal C-peptide [ Time Frame: 1 year ]
- The reduction in exogenous insulin requirements [ Time Frame: 1 year ]
- Decrease in HbA1c [ Time Frame: 1 year ]
- insulin area under the curve during OGTT [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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): NCT01374854
|Fuzhou General Hospital|
|Fuzhou, Fujian, China, 350025|
|Principal Investigator:||Jianming Tan, professor||Fuzhou General Hospital|
|Responsible Party:||Fuzhou General Hospital|
|Other Study ID Numbers:||
|First Posted:||June 16, 2011 Key Record Dates|
|Last Update Posted:||November 20, 2012|
|Last Verified:||November 2012|
type 1 diabetes mellitus
umbilical mesenchymal stem cell
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases