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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02624804
• Other study ID #: Pro 6262
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 27, 2017
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: December 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Stem Cell Educator Therapy
Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes

Locations

Country	Name	City	State
United States	Hackensack University Medical Center - John Theurer Cancer Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related adverse events	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.	12 months
Secondary	Number of patients unable to complete therapy	Number of patients who were unable to complete SCE Therapy.	One week