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

Part of paid clinical trials in Miami, Florida.

Sponsor
Creative Medical Technology Holdings Inc
Study ID
NCT05626712
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • CELZ-201 Administration — BIOLOGICAL
    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.
  • Control Group — OTHER
    Enhanced standard of care for Type 1 Diabetes treatment only.

Study Details

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).

Key Dates

Start date
Apr 7, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CELZ-201 Treatment Group
    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.
  • Placebo Comparator: Control Group
    Participants in this group will receive standard of care for Type 1 Diabetes only.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Diabetes Research Institute, University of Miami Miller School of MedicineMiamiFlorida33136
Francesco Vendrame, MD
(305) 243-5321
Francesco Vendrame, MD (PRINCIPAL_INVESTIGATOR)
Rodolfo Alejandro, MD (SUB_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Diabetes Research Institute, University of Miami Miller School of Medicine· Miami, FL

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