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

NCT02624804 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro 6262
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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 Outcomes (1)

• Number of Patients Unable to Complete Therapy

  One week

Study Arms (1)

Stem Cell Educator Therapy

EXPERIMENTAL

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

Biological: Stem Cell Educator Therapy

Interventions

Stem Cell Educator Therapy BIOLOGICAL

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

Also known as: Stem Cell Education

Stem Cell Educator Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Joshua Zenreich
• Organization: Hackensack Meridian Health

joshua.zenreich@hmhn.org

15519964248

Study Officials

• Michelle Donato, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: June 27, 2017
• Primary Completion: November 11, 2022
• Study Completion: March 11, 2024
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-07

Locations

US (1)