Stem Cell Educator therapy for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hackensack Meridian Health, Hackensack, NJ
Diabetes Mellitus+2 More
Stem Cell Educator therapy - CombinationProduct
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment for type 1 diabetes may be effective.

See full description

Eligible Conditions

  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus

Study Objectives

This trial is evaluating whether Stem Cell Educator therapy will improve 1 primary outcome and 4 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 6 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
Preliminary efficacy of SCE therapy to reduce insulin dose
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

Other trials for Diabetes Mellitus

Trial Design

2 Treatment Groups

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

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stem Cell Educator Therapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Treatment of T1D with Stem Cell Educator therapy
CombinationProduct
Recruited T1D subjects will receive one treatment with SCE therapy.
Conventional insulin therapy
CombinationProduct
Control group will receive conventional insulin therapy.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 month for reporting.

Closest Location

Hackensack Meridian Health - Hackensack, NJ

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

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 show original
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. show original
If a person's HbA1C is less than 10% at enrollment, they are likely to have good blood sugar control. show original
A continuous glucose monitoring system (CGMS) is required in order to participate in this study. show original
Adult patients ( 14 years)
The person must have diabetes mellitus that is type 1 in nature and was diagnosed using the 2015 American Diabetes Association criteria. show original
The person must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells show original
Fasting C-peptide level > 0.3 ng/ml
is a prerequisite for a successful procedure show original
Recent diagnosis (within two years of enrollment)

Patient Q&A Section

What are the signs of diabetes, autoimmune?

"Most diabetes related signs/symptoms are related to damage to the nervous system. Nerves such as the optic nerve and sensory nerves often show abnormalities on examination, and are more likely to suffer damage in diabetes. Some damage can be related to an autoimmune response. Autoimmune responses occur in many forms of diabetes, so it should be looked for systematically during diagnosis and follow up." - Anonymous Online Contributor

Unverified Answer

Can diabetes, autoimmune be cured?

"As of early 2002, there were no controlled studies to identify criteria or treatment which were universally effective in halting or regressing some features of both type 1 and [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes). However, for type 1, even with good care, a persistent high blood sugar level can be the main cause of chronic kidney disease. There is no evidence that any of the drugs currently available to treat diabetes cures or prevents diabetic kidney disease. The use of the nonpharmacological approaches to diabetes to improve diabetes control, and to prevent or delay its deterioration, seems to be more effective than pharmacological treatment of diabetes to prevent diabetic kidney disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes, autoimmune?

"While many of the treatments used in MS have positive effects on the general health of patients, there are certain treatment options which may lead to problems or complications. The goal should always be the improvement of the overall quality of life of patients." - Anonymous Online Contributor

Unverified Answer

What is diabetes, autoimmune?

"Diabetes represents an autoimmunological disease involving diabetes mellitus, whose autoantibodies target and attack components of the diabetic organ. The pathogenic mechanisms are quite complex and remain under investigation. These are multiple and are caused by T cells that use CD8 cells as antigen targets. These autoimmune processes may include defects in lymphatic transport, impaired clearance of the amyloid beta peptide, impaired regeneration of pancreatic islets, and aberrant activation and function of these cells by thymic stromal lymphopoietin (TSLP), an inflammatory cytokine, or by other factors associated with diabetes." - Anonymous Online Contributor

Unverified Answer

How many people get diabetes, autoimmune a year in the United States?

"An estimated 39 million people are diagnosed with type 1 or type 2 diabetes in the U.S. every year. This estimate is consistent with findings from previous studies." - Anonymous Online Contributor

Unverified Answer

What causes diabetes, autoimmune?

"The cause of diabetes is unknown, but there is a strong genetic component to type 1 diabetes, with the risk increasing with age. Diabetes can be triggered by lifestyle factors and genetics.\n" - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes, autoimmune?

"The findings do not allow a recommendation for which patients are suitable candidates for a clinical trial program related to diabetes for the purposes of achieving a new therapeutic target of diabetes." - Anonymous Online Contributor

Unverified Answer

What is stem cell educator therapy?

"Patients who choose not to pursue stem cell educator counseling may be at higher risk for poor glucose control after the 2-year visit. The authors recommend that patients contemplating such therapies consider the benefits before the burden of high-cost, frequent visits required for the treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of diabetes, autoimmune?

"Autoimmune diabetes is the most common form of diabetes, representing 40% of all diabetes cases. Diabetes was initially believed to be a secondary outcome, which might relate to autoimmunity as an initial cause." - Anonymous Online Contributor

Unverified Answer

Does diabetes, autoimmune run in families?

"Our evidence suggests that the disease may be influenced by genetic influences operating in a manner similar to type 1 diabetes and scleroderma. A high-resolution genomic strategy will elucidate the exact genetic basis of the disease." - Anonymous Online Contributor

Unverified Answer

Is stem cell educator therapy safe for people?

"The risk of adverse events and lack of clinical benefit do not justify the cost, risk and the adverse psychological effects of HSC educator therapy for people with IBD; however, these data support the theory that this safe procedure may be useful in patients with other conditions, particularly IBD and systemic autoimmune diseases." - Anonymous Online Contributor

Unverified Answer

Does stem cell educator therapy improve quality of life for those with diabetes, autoimmune?

"A non-commercial program of stem cell educator training on lifestyle for diabetes and autoimmune diabetes has positive effects on psychological distress, HbA1c and QoL scores." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus by sharing your contact details with the study coordinator.