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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Educator Therapy | Experimental | Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Educator Therapy | Biological | Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Unable to Complete Therapy | Number of patients who were unable to complete SCE Therapy. | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Donato, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stem Cell Educator Therapy | Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stem Cell Educator Therapy | Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients Experiencing Treatment Related Adverse Events | Posted | Count of Participants | Participants | 12 months |
|
From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stem Cell Educator Therapy | Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Zenreich | Hackensack Meridian Health | 15519964248 | joshua.zenreich@hmhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2019 | Jan 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients Unable to Complete Therapy | Number of patients who were unable to complete SCE Therapy. | Posted | Count of Participants | Participants | One week |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 4 |
| 8 |
| Body Aches | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Infection Strep Throat | Infections and infestations | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |