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NCT Number: NCT06731218

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, 300000, China

Location status: Recruiting

Location contact

Shusen Wang

PRINCIPAL_INVESTIGATOR

Zhongyang Shen

CONTACT

[email protected]

+86-22-23626606

Zhongyang Shen

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • Type 2 diabetes patients;
  • Untreated proliferative diabetes retinopathy;
  • Serious heart disease;
  • Serious gastrointestinal dysfunction ；
  • Serious psychological diseases；
  • Any history of malignancy;
  • Have a history of tobacco, alcohol and drug abuse;
  • For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.

Treatment and study plan

RGB-5088

Biological

Transplantation under the anterior rectus sheath

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Linlin Jiang

CONTACT

[email protected]

+86+571-88601920

Sponsors and collaborators

Lead sponsor

Hangzhou Reprogenix Bioscience, Inc

Industry

Registry information

Official study title

A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Dec 12, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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