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Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00767260
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Jianming Tan, Fuzhou General Hospital

Brief Summary:

There were evidences that the non-immune mediated inflammatory pathways of cell damage occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous stem cell therapies were an emerging set of therapies that showed promise with a low side effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained from bone marrow might provide multiple signals for regeneration and inflammation-induced lesion recovery of local tissues, of which the effect might be maximized by intra-arterial pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.

This trail includes a foregoing sub-trial that investigate the feasibility and safety of a novel method for massive bone marrow collection. The traditional BM collecting procedure is unfavorable because it yields minor bone marrow. Studies have shown that physiological exercise can increase bone marrow blood flow, which might facilitate BM collection.

We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to either a control group or an exercise group (n =30 each). The patients in the exercise group exercised 30 minutes before the operation. All patients underwent routine surgical care. The collected BM volume, operation time, collecting speed , puncture times and pain scores during the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and whole blood cell count.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: BM-MNC+HOT Drug: BM-MNC Device: HOT Drug: SMT Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cell Infusion With Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
Study Start Date : March 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: BM-MNC+HOT
Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy
Drug: BM-MNC+HOT
Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy

Experimental: BM-MNC
Autologous Bone Marrow mononuclear cell Infusion
Drug: BM-MNC
Autologous Bone Marrow Mononuclear cell Infusion

Experimental: HOT
hyperbaric oxygen therapy
Device: HOT
Hyperbaric Oxygen Therapy

Active Comparator: Control
stand medical therapy (enhanced hemoglucose monitor, health and diet counseling and insulin injection)
Drug: SMT
hypoglycemic drugs or exogenous insulin
Other Name: stand medical therapy (enhanced hemoglucose monitor, health and diet counseling and insulin injection)




Primary Outcome Measures :
  1. area under the curve of c-peptide [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The incidence and severity of adverse events related to the stem cell infusion procedure [ Time Frame: 1 year ]
  2. The incidence and severity of adverse events related to the hyperbaric oxygen therapy [ Time Frame: 1 year ]
  3. HbA1c [ Time Frame: 1 year ]
  4. exogenous insulin requirements [ Time Frame: 1 year ]
  5. fasting hemoglucose [ Time Frame: 1 year ]
  6. fasting c-peptide [ Time Frame: 1 year ]
  7. area under the curve of serum insulin [ Time Frame: 1 year ]


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

Inclusion Criteria:

  • Male and female patients age 40 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 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 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), Dipeptidyl-peptidase IV (DPP-IV) inhibitors (i.e. Sitagliptin, Januvia)
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

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): NCT00767260


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianming Tan, Vice President, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT00767260     History of Changes
Other Study ID Numbers: sc-dm-2008
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by Jianming Tan, Fuzhou General Hospital:
type 2 diabetes mellitus
bone marrow mononuclear cell
hyperbaric oxygen therapy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs