A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02624804 |
Recruitment Status :
Recruiting
First Posted : December 8, 2015
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus Type 1 | Biological: Stem Cell Educator Therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes |
Actual Study Start Date : | June 27, 2017 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Stem Cell Educator Therapy
Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes
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Biological: Stem Cell Educator Therapy
Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Other Name: Stem Cell Education |
- Treatment related adverse events [ Time Frame: 12 months ]The primary study endpoint will be the occurrence of treatment-related adverse effects. Adverse events that occur during therapy (especially those that necessitate temporary or permanent discontinuation of therapy) and over the 12-month follow-up period will be assessed.
- Number of patients unable to complete therapy [ Time Frame: One week ]Number of patients who were unable to complete SCE Therapy.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients >/=18 years
- Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes
- Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells (IAA, IA2, GAD 65, ZnT8)
- Fasting C-peptide level > 0.3 ng/ml
- Adequate venous access for apheresis
- Ability to provide informed consent
- Must agree to comply with all study requirements and be willing to complete all study visits
Exclusion Criteria:
- AST or ALT 2 > x upper limit of normal.
- Creatinine > 2.0 mg/dl.
- Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.
- Known active infection
- Pregnancy or breastfeeding mothers
- Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
- Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
- Anticoagulation other than ASA.
- Hemoglobin < 10 g/dl or platelets < 100 k/ml
- Is unable or unwilling to provide informed consent
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

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): NCT02624804
Contact: Michele Donato, MD | 551-996-8297 | Michele.Donato@hackensackmeridian.org | |
Contact: Mariefel Vendivil | 551-996-5828 | Mariefel.Vendivil@HackensackMeridian.org |
United States, New Jersey | |
Hackensack University Medical Center - John Theurer Cancer Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Mariefel Vendivil 551-996-5828 Mariefel.Vendivil@HackensackMeridian.org | |
Contact: Andrea Ortega 551-996-3923 Andre.Ortega@HackensackMeridian.org | |
Principal Investigator: Michele Donato, MD | |
Sub-Investigator: Robert Korngold, PhD | |
Sub-Investigator: Steven Ghanny, MD | |
Sub-Investigator: Scott Rowley, MD | |
Sub-Investigator: Alan Skarbnik, MD | |
Sub-Investigator: Phyllis McKiernan, APN | |
Sub-Investigator: David Vesole, MD, PhD | |
Sub-Investigator: Melissa Baker, APN | |
Sub-Investigator: Mary DiLorenzo, APN | |
Sub-Investigator: Michele Simone, APN | |
Sub-Investigator: Michele Boonstra, APN |
Principal Investigator: | Michelle Donato, MD | Hackensack Meridian Health |
Responsible Party: | Hackensack Meridian Health |
ClinicalTrials.gov Identifier: | NCT02624804 |
Other Study ID Numbers: |
Pro 6262 |
First Posted: | December 8, 2015 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |