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

NCT ID: NCT02624804

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2024-03-11

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

Conditions

Diabetes Mellitus Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem Cell Educator Therapy

Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes

Group Type: EXPERIMENTAL

Stem Cell Educator Therapy

Intervention Type: BIOLOGICAL

Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes

Interventions

Stem Cell Educator Therapy

Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes

Intervention Type: BIOLOGICAL

Other Intervention Names

Stem Cell Education

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Donato, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro 6262

Identifier Type: -

Identifier Source: org_study_id