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Type 2 Diabetes MellitusPhase 1/2NCT00767260

Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus

A Phase 1/2 study testing BM-MNC+HOT, BM-MNC and HOT in people with Type 2 Diabetes Mellitus, run by Fuzhou General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
BM-MNC+HOT, BM-MNC and HOT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteChina
Study dates
Mar 2008to Mar 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuzhou General Hospital

    Fuzhou, Fujian, 350025

Other trials in China

About this study

Official title: Autologous Bone Marrow Mononuclear Cell Infusion With Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

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.

Being tested
BM-MNC+HOT, BM-MNC, HOT, SMT
Keywords
type 2 diabetes mellitus, bone marrow mononuclear cell, hyperbaric oxygen therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BM-MNC+HOTDrug

    Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy

  • BM-MNCDrug

    Autologous Bone Marrow Mononuclear cell Infusion

  • HOTDevice

    Hyperbaric Oxygen Therapy

  • SMTDrug

    Also called stand medical therapy (enhanced hemoglucose monitor, health and diet counseling and insulin injection)

    hypoglycemic drugs or exogenous insulin

Study groups in NCT00767260
Study groupRoleWhat they receive
BM-MNC+HOTExperimentalAutologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy
Receives: Drug: BM-MNC+HOT
BM-MNCExperimentalAutologous Bone Marrow mononuclear cell Infusion
Receives: Drug: BM-MNC
HOTExperimentalhyperbaric oxygen therapy
Receives: Device: HOT
ControlActive comparatorstand medical therapy (enhanced hemoglucose monitor, health and diet counseling and insulin injection)
Receives: Drug: SMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. area under the curve of c-peptide

    Measured: 1 year

Secondary outcomes (7)

  1. The incidence and severity of adverse events related to the stem cell infusion procedure

    Measured: 1 year

  2. The incidence and severity of adverse events related to the hyperbaric oxygen therapy

    Measured: 1 year

  3. HbA1c

    Measured: 1 year

  4. exogenous insulin requirements

    Measured: 1 year

  5. fasting hemoglucose

    Measured: 1 year

  6. fasting c-peptide

    Measured: 1 year

  7. area under the curve of serum insulin

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2012
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00767260
Sponsor's protocol ID
sc-dm-2008
Status last verified
Sep 2017
First submitted
6 Oct 2008
Last updated
21 Sep 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Wu Z, Luo F, Wu Z, Tao X, Zou X, Tan J. Preoperative exercise facilitates abundant bone marrow collection in patients with type 2 diabetes for mononuclear cell therapy. Cytotherapy. 2015 Apr;17(4):454-7. doi: 10.1016/j.jcyt.2014.11.007. Epub 2015 Jan 2.

    PubMed 25559146

  • Wu Z, Cai J, Chen J, Huang L, Wu W, Luo F, Wu C, Liao L, Tan J. Autologous bone marrow mononuclear cell infusion and hyperbaric oxygen therapy in type 2 diabetes mellitus: an open-label, randomized controlled clinical trial. Cytotherapy. 2014 Feb;16(2):258-65. doi: 10.1016/j.jcyt.2013.10.004. Epub 2013 Nov 28.

    PubMed 24290656

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BM-MNC+HOT, BM-MNC and HOT in people with Type 2 Diabetes Mellitus, run by Fuzhou General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

area under the curve of c-peptide (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00767260, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.

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