Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT04011020|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Combination Product: Stem Cell Educator therapy||Phase 2 Phase 3|
The SCE device is made of a hydrophobic material from FDA-approved (USP Class VI) dishes that tightly binds stem cells CB-SCs without interfering with their immune modulating capability. We originally designed a chamber for co-culture of lymphocytes and CB-SCs that included nine discs of the material with a flow pathway and adherent CB-SCs sandwiched between a top cover plate and a bottom collecting plate. In this trial, we are going to use the 12-layer SCE device.
The SCE therapy carried a lower risk of infection than a typical blood transfusion, and did not introduce stem cells or reagents into the patients. In addition, CB-SCs have very low immunogenicity, and the CB-SCs cultured in the device are a highly restricted population and contain no CD3+ T cells or other lymphocyte subsets, eliminating the need for human leukocyte antigen (HLA) matching prior to treatment. This innovative approach has the potential to provide CB-SC-mediated immune modulation therapy for multiple autoimmune diseases while mitigating the safety and ethical concerns associated with other approaches such as T1D, type 2 diabetes (T2D), and alopecia areata (AA) in clinics. The relative simplicity of the approach may also provide cost and time savings relative to other approaches.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||All recruited T1D subjects will receive the treatment with Stem Cell Educator therapy.|
|Official Title:||Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||December 20, 2021|
Experimental: Treatment of T1D with Stem Cell Educator therapy
Recruited T1D subjects will receive one treatment with SCE therapy.
Combination Product: Stem Cell Educator therapy
Patients with T1D will be evaluated by the study principal investigator or co-investigators. Informed consent will be obtained at the initial screening visit. The initial screening visit will occur within 30 days of initiation of SCE therapy. The second screening visit will occur within 7 days of therapy. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the SCE system consisting of a single session of mononuclear cells (MNC) collection by apheresis where 10 L of blood will be processed on day -1. The MNC product will then be exposed over to the SCE and on day 0 the product will be infused intravenously back to the patient.
- Incidence of Treatment Adverse Events in T1D Subjects [ Time Frame: 6 month ]The occurrence of treatment-related adverse events will be evaluated post the treatment with SCE therapy.
- Preliminary efficacy of SCE therapy to improve beta cell function [ Time Frame: 12 months ]Preliminary efficacy as measured by Area under the C-peptide curve (AUC) over the first 2 hours of a 3-hour mixed meal tolerance test (MMTT)
- Preliminary efficacy of SCE therapy to improve glucose control [ Time Frame: 12 months ]Change in HbA1C levels over time
- Preliminary efficacy of SCE therapy to reduce insulin dose [ Time Frame: 12 months ]Change in daily insulin requirements
- Efficacy of SCE therapy in immune modulation [ Time Frame: 12 month ]Measurements of immune markers at baseline, 1, 3, 6, 9, and 12 months. Peripheral blood mononuclear cells (PBMC) will be collected and tested by flow cytometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011020
|Contact: YONG I ZHAO, MD,PhD||201 880 0290||Zhao@tianhecell.com|
|United States, New Jersey|
|Hackensack Meridian Health|
|Hackensack, New Jersey, United States, 07601|
|Study Chair:||YONG ZHAO, MD,PhD||Tianhe Stem Cell Biotechnologies Inc.|