Diabetes Mellitus, Type 2Phase 1/2ACESONCT02886884
Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
A Phase 1/2 study testing 20 million Allogeneic Mesenchymal Human Stem Cells and 100 million Allogeneic Mesenchymal Human Stem Cells in people with Diabetes Mellitus, Type 2, run by Joshua M Hare at 1 site in United States.
Trial summary
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 20 million Allogeneic Mesenchymal Human Stem Cells and 100 million Allogeneic Mesenchymal Human Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 3 Sep 2020
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 21 and < 90 (inclusive) years of age.
- Provide written informed consent.
- Have endothelial dysfunction defined by impaired flow-mediated vasodilation (FMD <7%).
- Have an ejection fraction > 45% by gated blood pool scan, two- dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the prior 3 months.
- Have Diabetes mellitus type 2 documented by hemoglobin adult type 1 component (A1C) > 7% or on medical therapy for diabetes.
- Females of childbearing potential must use two forms of birth control for the duration of the study. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
Who cannot join
- In order to participate in this study, a subject Must Not:
- Be younger than 21 years or older than 90 years of age.
- Have a baseline glomerular filtration rate <35 ml/min 1.73m^2 estimated using the Modification of Diet in renal disease (MDRD) formula.
- Have an ejection fraction <45% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the past year, as documented by medical history.
- Have poorly controlled blood glucose levels with hemoglobin A1C > 8.5%.
- Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
Show all 19Show fewer
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal.
- Have a bleeding diathesis or coagulopathy (INR > 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.
- Have Lymphadenectomy or Lymph node dissection in the right arm.
- Be an organ transplant recipient or have a history of organ or cell transplant rejection.
- Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively- treated basal cell or squamous cell carcinoma, or cervical carcinoma.
- Have a condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or Tumor Necrosis Factor - alpha (TNFα) antagonists.
- Be serum positive for HIV, Syphilis - VDRL (Confirmation with FTA-ABS if needed (Syphilis)), hepatitis B surface antigen or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
- Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: A Phase I/II, Randomized, Double Blind, Pilot Trial to Evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 20 million Allogeneic Mesenchymal Human Stem Cells, 100 million Allogeneic Mesenchymal Human Stem Cells
- Keywords
- Diabetes, Endothelial dysfunction, Stem cells
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 million Allogeneic Mesenchymal Human Stem CellsDrug
Also called allo-hMSCs, stem cells
1 single intravenous infusion
100 million Allogeneic Mesenchymal Human Stem CellsDrug
Also called allo-hMSCs, stem cells
1 single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Pilot Phase 20 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) Receives: Drug: 20 million Allogeneic Mesenchymal Human Stem Cells |
| Pilot Phase 100 million hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) Receives: Drug: 100 million Allogeneic Mesenchymal Human Stem Cells |
| Randomized Phase 20 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) Receives: Drug: 20 million Allogeneic Mesenchymal Human Stem Cells |
| Randomized Phase 100 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) Receives: Drug: 100 million Allogeneic Mesenchymal Human Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Serious Adverse Events (TE-SAEs)
TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Measured: Up to one month (post infusion)
Secondary outcomes (6)
EPC-CFU Levels
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
CRP Marker Levels
C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Angiogenic Factor Levels
Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Flow Mediated Diameter Percentage (FMD%)
FMD will be assessed using brachial artery ultrasound
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Inflammatory Marker Levels
Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Tumor Necrosis Factor (TNF) Alpha Levels
Measured from blood samples (pg/mL)
Measured: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start20 Oct 2017
- Primary completion26 Aug 2019
- Study completion3 Sep 2020
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 Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua M Hare
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Joshua M Hare, University of Miami
- Investigators
- Joshua M Hare, MD, Principal investigator, ISCI / University of Miami Miller School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886884
- Sponsor's protocol ID
- 20160686
- Other IDs
- 1R01HL134558-01
- Acronym
- ACESO
- Status last verified
- Apr 2022
- First submitted
- 29 Aug 2016
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double Blind, Pilot Trial to Evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT02886884
- Acronym / sponsor ID
- ACESO / 20160686
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Endothelial dysfunction, Stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Joshua M HareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Posted 11 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot Phase 20 million allogeneic hMSCs | Experimental | Drug: 20 million Allogeneic Mesenchymal Human Stem CellsParticipants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
| Pilot Phase 100 million hMSCs | Experimental | Drug: 100 million Allogeneic Mesenchymal Human Stem CellsParticipants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
| Randomized Phase 20 million allogeneic hMSCs | Experimental | Drug: 20 million Allogeneic Mesenchymal Human Stem CellsParticipants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
| Randomized Phase 100 million allogeneic hMSCs | Experimental | Drug: 100 million Allogeneic Mesenchymal Human Stem CellsParticipants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be ≥ 21 and < 90 (inclusive) years of age.
- Provide written informed consent.
- Have endothelial dysfunction defined by impaired flow-mediated vasodilation (FMD <7%).
- Have an ejection fraction > 45% by gated blood pool scan, two- dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the prior 3 months.
- Have Diabetes mellitus type 2 documented by hemoglobin adult type 1 component (A1C) > 7% or on medical therapy for diabetes.
Key exclusion criteria (19 listed)
- Be younger than 21 years or older than 90 years of age.
- Have a baseline glomerular filtration rate <35 ml/min 1.73m^2 estimated using the Modification of Diet in renal disease (MDRD) formula.
- Have an ejection fraction <45% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the past year, as documented by medical history.
- Have poorly controlled blood glucose levels with hemoglobin A1C > 8.5%.
- Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
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 |
|---|---|---|
| 20 million Allogeneic Mesenchymal Human Stem CellsAlso: allo-hMSCs, stem cells1 single intravenous infusion | Drug | Pilot Phase 20 million allogeneic hMSCs, Randomized Phase 20 million allogeneic hMSCs |
| 100 million Allogeneic Mesenchymal Human Stem CellsAlso: allo-hMSCs, stem cells1 single intravenous infusion | Drug | Pilot Phase 100 million hMSCs, Randomized Phase 100 million allogeneic hMSCs |
Primary outcome
Number of Treatment Emergent Serious Adverse Events (TE-SAEs)
Time frame: Up to one month (post infusion)
TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
6 secondary outcomes
EPC-CFU Levels
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
CRP Marker Levels
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Angiogenic Factor Levels
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Flow Mediated Diameter Percentage (FMD%)
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Inflammatory Marker Levels
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Tumor Necrosis Factor (TNF) Alpha Levels
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Interdisciplinary stem cell institute at the University of Miami websiteLink provided by the sponsor.
- 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.
Joshua M Hare, MD principal investigator
ISCI / 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 20 million Allogeneic Mesenchymal Human Stem Cells and 100 million Allogeneic Mesenchymal Human Stem Cells in people with Diabetes Mellitus, Type 2, run by Joshua M Hare 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 6 inclusion and 19 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 11 May 2022. 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 11 May 2022). 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 Treatment Emergent Serious Adverse Events (TE-SAEs) (time frame: Up to one month (post infusion)). 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 11 May 2022.