What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, SGLT2 inhibitors, and incretin-based therapies. Insulin therapy can cause hypoglycemia and weight gain. SGLT2 inhibitors, such as dapagliflozin, may lead to urinary tract infections and diabetic ketoacidosis. Incretin-based therapies, like GLP-1 analogues, can cause gastrointestinal issues such as nausea and vomiting. For treatments similar to CELZ-201, which involve immune modulation or beta cell regeneration, teplizumab has shown mild and limited-duration adverse events in trials, primarily involving immune modulation effects.

What prior FDA approvals exist?

For the treatment of Type 1 Diabetes, the FDA has approved immune-modulatory agents such as Teplizumab, an anti-CD3 monoclonal antibody, which has shown promise in preserving beta cell function by modulating the immune response. Another similar treatment is Otelixizumab, which also targets CD3 and aims to preserve beta cell function. These treatments are designed to alter the immune system's attack on pancreatic beta cells, similar to the approach being studied with CELZ-201.

What other types of research exist?

Promising novel alternatives to CELZ-201 for Type 1 Diabetes patients include: 1) Anti-CD3 monoclonal antibodies, such as Otelixizumab, which have shown safety and efficacy in preserving recall immunity in recent onset T1D patients. 2) IL-1-targeted biologics, although mixed results were noted, some agents like Anakinra have shown potential in treating immune-mediated disorders. 3) Iberdomide, which modulates immune cells and cytokines, showing significant clinical efficacy in autoimmune conditions like systemic lupus erythematosus, and may offer benefits in T1D by rebalancing immune abnormalities.

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Stem Cell Therapy

CELZ-201 for Type 1 Diabetes (CREATE-1 Trial)

Phase 1 & 2

Recruiting

Led By Camillo Ricordi, MD

Research Sponsored by Creative Medical Technology Holdings Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with eGFR >80 ml/min/1.73m2

Males and females, 18-35 years of age

Must not have

Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization

Subjects with poorly controlled hypertension as defined by systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Summary

This trial is testing CELZ-201, a new treatment for people who have just been diagnosed with Type 1 Diabetes. The treatment is given directly into the bloodstream to help control blood sugar levels.

Who is the study for?

Adults aged 18-35 with recent onset Type 1 Diabetes, confirmed by specific autoantibodies and a certain level of C-peptide. Participants must be mentally stable, able to follow the study protocol, manage their diabetes as usual, have good kidney function and venous access for blood draws. Women must not be pregnant or breastfeeding and along with men, agree to use two forms of birth control during the study.

What is being tested?

The trial is testing CELZ-201's safety and effectiveness when given through an artery in patients who've recently been diagnosed with Type 1 Diabetes Mellitus. A control group will not receive CELZ-201. The goal is to see if this treatment can help manage diabetes better than current standard care.

What are the potential side effects?

Specific side effects are not listed but may include reactions related to intra-arterial administration such as discomfort at injection site or allergic reactions including anaphylaxis especially in those sensitive to heparin or iodine contrast used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good.

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I am between 18 and 35 years old.

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I agree to use two approved birth control methods for 2 years.

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I have Type 1 Diabetes confirmed by specific autoantibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken immunosuppressives, immunomodulators, or cytotoxic drugs in the last 3 months.

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My blood pressure is not higher than 140/90 mmHg.

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I do not have liver disease, blood clotting disorders, or take long-term blood thinners (except for low-dose aspirin).

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I do not have any current infections like colds, UTIs, or stomach bugs.

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I do not have chronic infections like hepatitis, tuberculosis, or HIV.

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I am using or plan to use diabetes medications besides insulin.

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I have a history of heart disease or significant heart test abnormalities.

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I have a history of severe stomach or digestive problems.

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I have symptoms of gallstones, pancreatitis, or stomach ulcers.

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I have received an organ transplant.

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I am a man and will use contraception during the study if my partner could become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Alloreactive Antibody Levels

C-peptide during a 4-hour MMTT

Glycosylated HbA1C

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CELZ-201 Treatment GroupExperimental Treatment1 Intervention

Participants in this group will receive a single dose of CELZ-201, in addition to standard of care of care for Type 1 Diabetes treatment.

Group II: Control GroupPlacebo Group1 Intervention

Participants in this group will receive standard of care for Type 1 Diabetes only.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes focus on immune modulation and beta cell regeneration. Immune modulation therapies, such as anti-CD3 antibodies (e.g., teplizumab) and anti-CD20 antibodies, aim to reduce the autoimmune attack on pancreatic beta cells, thereby preserving their function. Beta cell regeneration therapies, including cellular therapies like CELZ-201, aim to restore or replace the damaged beta cells to improve insulin production. These treatments are crucial for Type 1 Diabetes patients as they address the underlying autoimmune cause of the disease and have the potential to reduce or eliminate the need for exogenous insulin, improving long-term glycemic control and quality of life.