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Cell Therapy

Pancreatic Cell Implants for Type 1 Diabetes (SUGR Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Seraxis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to use continuous glucose monitoring
Adult 18 to 65 years with a clinical history of T1D
Must not have
Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
Weight loss medication(s) within 3 months of Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new treatment called SR-02 on patients with Type 1 diabetes who experience severe recurrent low blood sugar. The goal is to see if SR-02 is safe, effective,

Who is the study for?
This trial is for individuals with Type 1 diabetes who frequently experience severe low blood sugar episodes. Participants must be willing to undergo immunosuppression therapy to prevent their body from rejecting the treatment.
What is being tested?
The study tests the safety and effectiveness of implanting pancreatic endocrine cell clusters into the omentum (a part of the abdomen) in patients with Type 1 diabetes, aiming to find the best dose.
What are the potential side effects?
Possible side effects include those related to immunosuppression such as increased risk of infections, reaction at implant site, and potential rejection of implanted cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to use a device to monitor my blood sugar levels continuously.
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I am between 18 and 65 years old and have been diagnosed with Type 1 Diabetes.
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I was diagnosed with Type 1 Diabetes before turning 40.
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I have been dependent on insulin for 5 or more years.
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I frequently experience severe low blood sugar.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken diabetes medication other than insulin in the last 3 months.
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I have not taken weight loss medications in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SR-02 Allogeneic pancreatic endocrine cell clustersExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

SeraxisLead Sponsor
~6 spots leftby Mar 2027
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