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A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes

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. Identifier: NCT02624804
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
This is a prospective, single arm, open-label, single-center pilot study to assess the safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients with Type 1 Diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Biological: Stem Cell Educator Therapy Phase 1

Detailed Description:
Our previous work demonstrated that human cord blood-derived multipotent stem cells (CB-SCs) are a unique type of stem cell identified from human cord blood, distinct from other stem cell types including hematopoietic stem cells (HSCs), and mesenchymal stem cells (MSCs). The stem cells and harnessed some of their unique properties with Stem Cell Educator therapy by using CB-SCs in a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and returns the "educated" lymphocytes (but not the CB-SCs) to the patient's circulation . This treatment leads to global immune modulations and immune balance as demonstrated by clinical data and animal studies. The Stem Cell Educator therapy may revolutionize the clinical treatment of diabetes and other immune-related diseases through CB-SCs' immune education and induction of immune balance, without the safety and ethical concerns associated with conventional stem cell-based approaches

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of patients unable to complete therapy [ Time Frame: One week ]
    Number of patients who were unable to complete SCE Therapy.

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02624804

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Contact: Michele Donato, MD 551-996-8297
Contact: Mariefel Vendivil 551-996-5828

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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   
Contact: Andrea Ortega    551-996-3923   
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         
Sponsors and Collaborators
Hackensack Meridian Health
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Principal Investigator: Michelle Donato, MD Hackensack Meridian Health
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Responsible Party: Hackensack Meridian Health 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hackensack Meridian Health:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases