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

Primary Purpose

Diabetes Mellitus Type 1

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stem Cell Educator Therapy

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hackensack University Medical Center - John Theurer Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Educator Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients unable to complete therapy

Number of patients who were unable to complete SCE Therapy.

Full Information

NCT ID

NCT02624804

First Posted

December 4, 2015

Last Updated

December 1, 2022

Sponsor

Hackensack Meridian Health

1. Study Identification

Unique Protocol Identification Number

NCT02624804

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

November 11, 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 1

Keywords

Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stem Cell Educator Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Stem Cell Educator Therapy

Other Intervention Name(s)

Stem Cell Education

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment related adverse events

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of patients unable to complete therapy

Description

Number of patients who were unable to complete SCE Therapy.

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Donato, MD

Organizational Affiliation

Hackensack Meridian Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hackensack University Medical Center - John Theurer Cancer Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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