Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02624804
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Tracking Information
First Submitted Date  ICMJE December 4, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE June 27, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02624804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
Number of patients unable to complete therapy [ Time Frame: One week ]
Number of patients who were unable to complete SCE Therapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Official Title  ICMJE A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 1
Intervention  ICMJE Genetic: 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
Study Arms  ICMJE Experimental: Stem Cell Educator Therapy
Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes
Intervention: Genetic: Stem Cell Educator Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michele Donato, MD 551-996-8297 Michele.Donato@hackensackmeridian.org
Contact: Mariefel Vendivil 551-996-5828 Mariefel.Vendivil@HackensackMeridian.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624804
Other Study ID Numbers  ICMJE Pro 6262
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hackensack Meridian Health
Study Sponsor  ICMJE Hackensack Meridian Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Donato, MD Hackensack Meridian Health
PRS Account Hackensack Meridian Health
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP