Stem Cell Educator therapy for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetes Mellitus+2 More
Stem Cell Educator therapy - CombinationProduct
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial uses a patient's own immune cells that are "educated" by cord blood stem cells in order to improveC-peptide levels, reduce median glycated hemoglobin A1C (HbA1C) values, and decrease median daily usage of insulin in Type 1 diabetes (T1D) patients.

Eligible Conditions
  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 month

12 month
Efficacy of SCE therapy in immune modulation
12 months
Preliminary efficacy of SCE therapy to improve beta cell function
Preliminary efficacy of SCE therapy to improve glucose control
Insulin
6 month
Incidence of Treatment Adverse Events in T1D Subjects

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment of T1D with Stem Cell Educator therapy
1 of 2
Conventional insulin therapy
1 of 2
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Stem Cell Educator therapy · No Placebo Group · Phase 2 & 3

Treatment of T1D with Stem Cell Educator therapy
CombinationProduct
Experimental Group · 1 Intervention: Stem Cell Educator therapy · Intervention Types: CombinationProduct
Conventional insulin therapy
CombinationProduct
Experimental Group · 1 Intervention: Stem Cell Educator therapy · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month

Who is running the clinical trial?

Hackensack Meridian HealthOTHER
110 Previous Clinical Trials
23,547 Total Patients Enrolled
2 Trials studying Diabetes Mellitus
59 Patients Enrolled for Diabetes Mellitus
Throne Biotechnologies Inc.Lead Sponsor
6 Previous Clinical Trials
290 Total Patients Enrolled
3 Trials studying Diabetes Mellitus
220 Patients Enrolled for Diabetes Mellitus
YONG ZHAO, MD,PhDStudy ChairThrone Biotechnologies Inc.

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
is important, but one's ability to provide meaningful consent may be compromised if he or she is incapacitated
The study is only for female patients who are willing to use birth control that is recommended by the FDA until 6 months after treatment.
If a person's HbA1C is less than 10% at enrollment, they are likely to have good blood sugar control.
A continuous glucose monitoring system (CGMS) is required in order to participate in this study.
The person must have diabetes mellitus that is type 1 in nature and was diagnosed using the 2015 American Diabetes Association criteria.
The person must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells
is a prerequisite for a successful procedure

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas25.0%
New York25.0%
Florida25.0%
Other25.0%
How old are they?
18 - 6566.7%
< 1833.3%
What site did they apply to?
Hackensack Meridian Health100.0%
What portion of applicants met pre-screening criteria?
Met criteria40.0%
Did not meet criteria60.0%
How many prior treatments have patients received?
0100.0%
References