Type 2 Diabetes MellitusPhase 1/2HOTNCT01786707
Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
A Phase 1/2 study testing Autologous stem cells, Hyperbaric oxygen therapy and Insulin in people with Type 2 Diabetes Mellitus, run by Rodolfo Alejandro at 1 site in United States.
Trial summary
A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Autologous stem cells, Hyperbaric oxygen therapy and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 45 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 as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus.
- Onset of Type 2 DM disease at 40 years of age.
- T2DM duration: 2-15 years at the time of enrollment.
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- Basal C-peptide: 0.3 ng/mL
- HbA1c of 7.5-12.5% before standard medical therapy. Patients must have been treated with SMT for minimum of 4 months prior to randomization. Insulin and metformin doses should be stable over the 3 months prior to randomization.
- HbA1c: 7.5-9.5% at time of randomization.
- Total insulin daily dose at baseline and at randomization <100 units/day.
Who cannot join
- BMI >40 kg/m2.
- Insulin requirements of >100 U/day, and HbA1c >9.5%
- C-reactive protein >10.00
- Uncontrolled blood pressure: Systolic Blood Pressure >140 mmHg or Diastolic Blood Pressure >80 mmHg Evidence of renal dysfunction, serum creatinine > 1.5 mg/dl (males) and 1.4 mg/dl (females)
- Proteinuria >300 mg/day
- History or EKG evidence of myocardial infarction or any degree of heart failure
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- Female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. Male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception.
- Active infection including hepatitis B, hepatitis C, HIV, or Tuberculosis. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection.
- 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 International normalized ratio (INR) >1.5, Partial thromboplastin time (PTT) >40, Prothrombin time (PT) >15.
- Acute or chronic pancreatitis.
- Symptomatic peptic ulcer disease.
- Hyperlipidemia despite medical therapy
- Receiving treatment for a medical condition requiring chronic use of systemic corticosteroids in the past six months.
- 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.
- History or presence of active proliferative diabetic retinopathy or macular edema.
- Any malignancy.
- Hepatic enzyme levels upper normal limits.
- Total bilirubin upper normal limits unless secondary to known benign condition.
- 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.
- Hypoproteinemia, cachexia or terminal states; history of anorexia/bulimia; respiratory insufficiency; 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 treated with any medication that could interfere with the outcome of the study.
- Subjects positive for auto-antibodies
- History of Cushing syndrome (endogenous or iatrogenic).
- History of allergy to iodine or iodinated materials.
- Abnormal thyroid function
- 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.
United States1 site
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Phase 2 Study of Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be randomized into either the intervention group or the control group:
Read the detailed description
This is a phase I/II, prospective, randomized case controlled study in patients with Type 2 Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve glycemic control and pancreatic function in T2DM patients compared to controls receiving standard medical treatment (SMT) with metformin and insulin alone.
New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may decrease the incidence and progression of T2DM chronic complications and together with achievable life style changes may improve general health and quality of life of T2DM patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent a combined treatment using ASC+HBO showed a significant progressive and consistent reduction in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in the number and dose of oral agents and/or insulin. These encouraging preliminary results require confirmation in a controlled, randomized prospective trial.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Hyperbaric oxygen therapy (HOT), Autologous Bone Marrow-Derived Buffy Coat, Stem cells (SC)
- 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.
Autologous stem cellsBiological
Pancreatic artery infusion of Autologous Stem cells.
Hyperbaric oxygen therapyOther
InsulinDrug
Insulin dose as per clinical management
MetforminDrug
Metformin dose as tolerated
| Study group | Role | What they receive |
|---|---|---|
| Autologous SC and HOT | Experimental | Autologous stem cells and hyperbaric oxygen therapy Receives: Biological: Autologous stem cells; Other: Hyperbaric oxygen therapy; Drug: Insulin; Drug: Metformin |
| Control group | Active comparator | Patients in a control group will continue with standard medical treatment (Insulin and Metformin) Receives: Drug: Insulin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Reduction of HbA1c of >0.5%
Measured: 1 year
Secondary outcomes (1)
The Number of Subjects With a Reduction of >1% in HbA1c
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodolfo Alejandro
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Research Institute Foundation
- Responsible party
- Sponsor-investigator, Rodolfo Alejandro, University of Miami
- Investigators
- Rodolfo Alejandro, MD, Principal investigator, Diabetes Research Institute, University of Miami Miller School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786707
- Sponsor's protocol ID
- 20070881
- Acronym
- HOT
- Status last verified
- Jun 2017
- First submitted
- 5 Feb 2013
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01786707
- Acronym / sponsor ID
- HOT / 20070881
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Hyperbaric oxygen therapy (HOT), Autologous Bone Marrow-Derived Buffy Coat, Stem cells (SC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rodolfo AlejandroUniversity, hospital or other
- Collaborators
- Diabetes Research Institute Foundation
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be randomized into either the intervention group or the control group:
Detailed description
This is a phase I/II, prospective, randomized case controlled study in patients with Type 2 Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve glycemic control and pancreatic function in T2DM patients compared to controls receiving standard medical treatment (SMT) with metformin and insulin alone.
New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may decrease the incidence and progression of T2DM chronic complications and together with achievable life style changes may improve general health and quality of life of T2DM patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent a combined treatment using ASC+HBO showed a significant progressive and consistent reduction in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in the number and dose of oral agents and/or insulin. These encouraging preliminary results require confirmation in a controlled, randomized prospective trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous SC and HOT | Experimental | Biological: Autologous stem cells, Other: Hyperbaric oxygen therapy, Drug: Insulin, Drug: MetforminAutologous stem cells and hyperbaric oxygen therapy |
| Control group | Active comparator | Drug: Insulin, Drug: MetforminPatients in a control group will continue with standard medical treatment (Insulin and Metformin) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients age 45 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 as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus.
- Onset of Type 2 DM disease at 40 years of age.
Key exclusion criteria (34 listed)
- BMI >40 kg/m2.
- Insulin requirements of >100 U/day, and HbA1c >9.5%
- C-reactive protein >10.00
- Uncontrolled blood pressure: Systolic Blood Pressure >140 mmHg or Diastolic Blood Pressure >80 mmHg Evidence of renal dysfunction, serum creatinine > 1.5 mg/dl (males) and 1.4 mg/dl (females)
- Proteinuria >300 mg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous stem cellsPancreatic artery infusion of Autologous Stem cells. | Biological | Autologous SC and HOT |
| Hyperbaric oxygen therapy | Other | Autologous SC and HOT |
| InsulinInsulin dose as per clinical management | Drug | Autologous SC and HOT, Control group |
| MetforminMetformin dose as tolerated | Drug | Autologous SC and HOT, Control group |
Primary outcome
Number of Participants With a Reduction of HbA1c of >0.5%
Time frame: 1 year
1 secondary outcome
The Number of Subjects With a Reduction of >1% in HbA1c
Time frame: at 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo Alejandro, MD principal investigator
Diabetes Research Institute, University of Miami Miller School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous stem cells, Hyperbaric oxygen therapy and Insulin in people with Type 2 Diabetes Mellitus, run by Rodolfo Alejandro at 1 site in United States.
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 34 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 2 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Reduction of HbA1c of >0.5% (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.