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Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus

ConditionsDiabetes Mellitus, Type 1Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHangzhou Reprogenix Bioscience, Inc

About this trial

This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-60 years old (including 18 and 60 years old), male and female;

Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);

Stimulated C-peptide < 0.3 ng/mL;

The patient had at least one severe hypoglycemia within 12 months before being included in the project

Disqualifiers

Type 2 diabetes patients;

Untreated proliferative diabetes retinopathy;

Serious heart disease;

Serious gastrointestinal dysfunction ；

Trial design

Design model

Single group

Treatments tested in this trial

  • RGB-5088

    Biological/Vaccine

    Transplantation under the anterior rectus sheath

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: RGB-5088Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety as assessed by number of subjects with adverse events

Time frame
From RGB-5088 transplantation to one year later
2

Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events

Time frame
From 90 days to 365 days after RGB-5088 transplantation

Secondary outcomes

1

Safety as assessed by number of subjects with adverse events

Time frame
From RGB-5088 transplantation to end of study (up to 5 years)
2

Proportion of subjects who are insulin independent

Time frame
From 90 days to end of study (up to 5 years)
3

Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events

Time frame
From 90 days to end of study (up to 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Reprogenix Bioscience, Inc

Lead sponsor

Source ClinicalTrials.gov
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