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Type 1 DiabetesPhase 1/2CREATE-1NCT05626712

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

A Phase 1/2 study testing CELZ-201 Administration in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Creative Medical Technology Holdings Inc at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Type 1 Diabetes, Diabetes Mellitus, Type 1
What is being tested?
CELZ-201 Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
7 Apr 2023to 31 Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • Subjects with liver disease, portal hypertension, any coagulopathy (including history of Factor V deficiency) or long-term anti-coagulant therapy (except low-dose aspirin). Other hepatic conditions including hepatic anatomic abnormalities or variants that would place the individual at increased risk in the judgment of the investigator are also considered exclusionary.
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  • 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.
  • Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
  • History or diagnosis of malignancy with the exception of a history of localized basal or squamous cell carcinoma.
  • Any history of gastroparesis or other severe gastrointestinal disease.
  • Presence of an allograft.
  • Diagnosed or self-reported drug or alcohol abuse.
  • An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
  • Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire 2-year duration of the study.
  • Inability to perform any of the assessments required for endpoint analysis.
  • Known history of serious allergic reactions, including anaphylaxis to CELZ-201 or its preparation components. Specifically, patients with a prior history of heparin induced thrombocytopenia or any other adverse reaction to heparin, will be excluded.
  • The investigator believes that participating in the trial is not in the best interest of the patient, or the investigator considers patient unsuitable for enrollment (such as unpredictable risks or subject compliance issues).
  • Positive for coronavirus disease (COVID)-19 by PCR or evidence of active infection per local institutional standards.
  • Allergy to iodine contrast or anesthesia
  • For female subjects: Pregnant, nursing, or planning to become pregnant during the course of entire duration of the study (approximately little over two years) or unwillingness to comply with contraceptive requirements.
  • For male subjects: Male subjects with a female partner who is planning to become pregnant with the male subject during the entire course of the study or unwillingness to comply with contraceptive requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Creative Medical Technology contact

(702) 588-1890

clinicaltrials@creativemedicaltechnology.com

United States1 site, 1 recruiting

  • Diabetes Research Institute, University of Miami Miller School of Medicine

    Miami, Florida, 33136

    Francesco Vendrame, MD, (305) 243-5321

    Francesco Vendrame, MD

    Recruiting

Other trials in United States

About this study

Official title: Clinical Trial to Evaluate the Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (CREATE-1)

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).

Read the detailed description

The proposed study is a Phase I/IIa randomized, controlled clinical trial to evaluate CELZ-201 therapy as an intervention for the treatment of recent onset Type 1 Diabetes. The objective is to determine the safety and efficacy of CELZ-201 administration, based on the timing and dose of CELZ-201 treatment. Subjects who meet eligibility criteria will be randomized to treatment or control groups, in a 2:1 ratio. Subjects in the Group I (Treatment Group, n=12) will receive standard of care for type 1 diabetes and CELZ-201 within 1 month from enrollment (within 1 year of diagnosis). Subjects in Group II (Control Arm, n=6) and will receive enhanced standard of care for type 1 diabetes.

Being tested
CELZ-201 Administration, Control Group
Keywords
Recent Onset Type 1 Diabetes, Adult Onset Type 1 Diabetes, Type 1 Diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Control GroupOther

    Enhanced standard of care for Type 1 Diabetes treatment only.

Study groups in NCT05626712
Study groupRoleWhat they receive
CELZ-201 Treatment GroupExperimentalParticipants in this group will receive a single dose of CELZ-201, in addition to standard of care of care for Type 1 Diabetes treatment.
Receives: Biological: CELZ-201 Administration
Control GroupPlacebo comparatorParticipants in this group will receive standard of care for Type 1 Diabetes only.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (7)

  1. Number of Participants with Adverse Events

    Incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 12 months.

    Measured: 12 months

  2. Number of Participants with Adverse Events

    Incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 24 months.

    Measured: 24 months

  3. Glycosylated HbA1C

    Changes in glycosylated HbA1c (%)

    Measured: 12 months

  4. Insulin Requirement

    Changes in exogenous insulin requirement

    Measured: 12 months

  5. Islet Autoantibody Levels

    Changes in islet autoantibody levels GAD65 (U/mL), IA2 (U/mL), and ZnT8 (U/mL)

    Measured: 12 months

  6. Alloreactive Antibody Levels

    Changes in alloreactive antibody levels (U/mL)

    Measured: 12 months

  7. C-peptide during a 4-hour MMTT

    Changes in fasting, peak stimulated and AUC C-peptide (ng/mL) during a 4-hour MMTT

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start7 Apr 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626712
Sponsor's protocol ID
CELZ-201-001
Acronym
CREATE-1
Status last verified
Feb 2026
First submitted
7 Nov 2022
Last updated
19 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CELZ-201 Administration in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Creative Medical Technology Holdings Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Creative Medical Technology ((702) 588-1890, clinicaltrials@creativemedicaltechnology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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