MSC and BMMNC in Type 2 Diabetes Mellitus
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: infusion of BMMSCs Drug: infusion BMMNCs Drug: insulin | Phase 1 Phase 2 |
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 |

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 |
- HbA1c [ Time Frame: 1y ]
- 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 ]

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 |
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.

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
China, Fujian | |
Fuzhou General Hospital, Xiamen Univ | |
Fuzhou, Fujian, China, 350025 |
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: | 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 |
mesenchymal stem cells bone marrow mononeclear cells type 2 diabetes mellitus |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |