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Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes

NCT05626712 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-19

No results posted yet for this study

Summary

The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).

Conditions

Interventions

BIOLOGICAL

CELZ-201 Administration

Participants in this group will receive a single dose of CELZ-201, in addition to standard of care for Type 1 Diabetes treatment. Perinatal tissue derived cells will be administered at a dose of 1x10\^6 cells/kg via an intra-arterial infusion into the dorsal pancreatic artery.

OTHER

Control Group

Enhanced standard of care for Type 1 Diabetes treatment only.

Sponsors & Collaborators

  • Creative Medical Technology Holdings Inc

    lead INDUSTRY

Principal Investigators

  • Francesco Vendrame, MD · University of Miami, Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626712 on ClinicalTrials.gov