Clinical trial NCT02624804: A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Official title: A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Keywords: Diabetes
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients Unable to Complete Therapy
timeFrame: One week
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center - John Theurer Cancer Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Michelle Donato, MD
role: PRINCIPAL_INVESTIGATOR
References: