NCT05626712

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
21mo left

Started Apr 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2023Jan 2028

First Submitted

Initial submission to the registry

November 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

November 7, 2022

Last Update Submit

February 17, 2026

Conditions

Type 1 DiabetesDiabetes Mellitus, Type 1

Keywords

Recent Onset Type 1 DiabetesAdult Onset Type 1 DiabetesType 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    The primary outcome to be assessed is tolerability and safety of the CELZ-201 therapy. The incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 6 months.

    6 months

Secondary Outcomes (7)

  • Number of Participants with Adverse Events

    12 months

  • Number of Participants with Adverse Events

    24 months

  • Glycosylated HbA1C

    12 months

  • Insulin Requirement

    12 months

  • Islet Autoantibody Levels

    12 months

  • +2 more secondary outcomes

Study Arms (2)

CELZ-201 Treatment Group

EXPERIMENTAL

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.

Biological: CELZ-201 Administration

Control Group

PLACEBO COMPARATOR

Participants in this group will receive standard of care for Type 1 Diabetes only.

Other: Control Group

Interventions

CELZ-201 AdministrationBIOLOGICAL

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.

CELZ-201 Treatment Group
Control GroupOTHER

Enhanced standard of care for Type 1 Diabetes treatment only.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject must be able to understand and provide signed informed consent.
  • Males and females, 18-35 years of age.
  • Diagnosis of T1D within 1 year, with stimulated C-peptide peak level \>0.6 ng/mL as assessed by 4-hour MMTT at the time of Visit 0 (screening).
  • Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity to at least two islet autoantibodies, GAD65, IA-2, or ZnT8.
  • Mentally stable and able to comply with the procedures of the study protocol
  • Subjects must be willing to comply with "standard-of-care" diabetes management.
  • Subjects with eGFR \>80 ml/min/1.73m2
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
  • Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study.
  • Potential subjects of childbearing potential should agree to use effective contraception for the entire 2-year period.
  • Adequate venous access to support study required blood draws.

You may not qualify if:

  • Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
  • BMI\>28 kg/m.
  • HbA1c \> 9%
  • Subjects with poorly controlled hypertension as defined by systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg.
  • Subjects with any history of cardiac disease, including but not limited to myocardial infarction, uncompensated heart failure, fluid overload, as well as any clinically significant abnormality identified on prior cardiac stress test, angiogram evaluation, or echocardiogram.
  • Symptomatic cholecystolithiasis; acute or chronic pancreatitis; or current symptomatic peptic ulcer disease.
  • Subjects with uncontrolled thyroid disease: thyroid stimulating hormone \<0.3 mU/L or \>5 mU/L; free T4 \<5.0 ug/dL or \>11.0 ug/dL.
  • Any of the following laboratory findings: hemoglobin \<11.5 g/dL (females) or \<13.2 g/dL (males); leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL; elevation in AST and ALT \>2 x ULN (upper limit of normal); LDL cholesterol \>160; Triglycerides \>3 x ULN; total bilirubin \>1.5 x ULN.
  • Screening laboratory evidence consistent with significant chronic active infection (i.e.., hepatitis B and C, tuberculosis, and HIV), and IGRA Tuberculosis (Tb) test during screening
  • Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.
  • Subjects with eating disorders.
  • Ongoing or anticipated use of diabetes medications other than insulin.
  • Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 7 days of screening.
  • Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
  • Patients who have participated in previous clinical studies, other than observational studies, will be excluded.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Francesco Vendrame, MD

    University of Miami, Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Creative Medical Technology

CONTACT

(702) 588-1890clinicaltrials@creativemedicaltechnology.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a two-arm, open label, randomized trial. Subjects who meet eligibility criteria will be randomized to treatment or control groups in a 2:1 ratio.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 25, 2022

Study Start

April 7, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)