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Stem Cell Therapy
CELZ-201 for Type 1 Diabetes (CREATE-1 Trial)
Phase 1 & 2
Recruiting
Led By Camillo Ricordi, MD
Research Sponsored by Creative Medical Technology Holdings Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with eGFR >80 ml/min/1.73m2
Males and females, 18-35 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
CREATE-1 Trial Summary
This trial tests a new potential treatment for Type 1 Diabetes Mellitus that targets arteries.
Who is the study for?
Adults aged 18-35 with recent onset Type 1 Diabetes, confirmed by specific autoantibodies and a certain level of C-peptide. Participants must be mentally stable, able to follow the study protocol, manage their diabetes as usual, have good kidney function and venous access for blood draws. Women must not be pregnant or breastfeeding and along with men, agree to use two forms of birth control during the study.Check my eligibility
What is being tested?
The trial is testing CELZ-201's safety and effectiveness when given through an artery in patients who've recently been diagnosed with Type 1 Diabetes Mellitus. A control group will not receive CELZ-201. The goal is to see if this treatment can help manage diabetes better than current standard care.See study design
What are the potential side effects?
Specific side effects are not listed but may include reactions related to intra-arterial administration such as discomfort at injection site or allergic reactions including anaphylaxis especially in those sensitive to heparin or iodine contrast used during the procedure.
CREATE-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good.
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I am between 18 and 35 years old.
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I agree to use two approved birth control methods for 2 years.
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I have Type 1 Diabetes confirmed by specific autoantibodies.
CREATE-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Alloreactive Antibody Levels
C-peptide during a 4-hour MMTT
Glycosylated HbA1C
+3 moreCREATE-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CELZ-201 Treatment GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupPlacebo Group1 Intervention
Participants in this group will receive standard of care for Type 1 Diabetes only.
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Who is running the clinical trial?
Creative Medical Technology Holdings IncLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Camillo Ricordi, MDPrincipal InvestigatorUniversity of Miami, Diabetes Research Institute
4 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an eating disorder.Your HbA1c level is higher than 9%.My blood pressure is not higher than 140/90 mmHg.I am mentally stable and can follow study instructions.I do not have liver disease, blood clotting disorders, or take long-term blood thinners (except for low-dose aspirin).I do not have any current infections like colds, UTIs, or stomach bugs.I have had cancer before, but only skin cancer like basal or squamous cell carcinoma.I do not have chronic infections like hepatitis, tuberculosis, or HIV.You have tested positive for COVID-19 or show signs of an active infection according to local medical guidelines.My kidney function is good.I am between 18 and 35 years old.I haven't taken immunosuppressives, immunomodulators, or cytotoxic drugs in the last 3 months.I am of childbearing age and have a negative pregnancy test.I am using or plan to use diabetes medications besides insulin.You have had a serious allergic reaction to CELZ-201 or its components, or have had a bad reaction to heparin in the past.Your body mass index (BMI) is greater than 28.Your blood test results show low levels of hemoglobin, leukocytes, neutrophils, lymphocytes, or platelets, or high levels of AST, ALT, LDL cholesterol, triglycerides, or total bilirubin.You have uncontrolled thyroid disease, with hormone levels outside the normal range.I have a history of heart disease or significant heart test abnormalities.I was diagnosed with type 1 diabetes less than 6 months ago and my C-peptide level is above 0.6 ng/mL.I agree to use two approved birth control methods for 2 years.I haven't received any live vaccines in the last 6 weeks.I have a history of severe stomach or digestive problems.I have Type 1 Diabetes confirmed by specific autoantibodies.I can have blood drawn without difficulty.I have symptoms of gallstones, pancreatitis, or stomach ulcers.I am using non-insulin diabetes medication.I have received an organ transplant.I am a man and will use contraception during the study if my partner could become pregnant.You have a history of using drugs or alcohol excessively.
Research Study Groups:
This trial has the following groups:- Group 1: CELZ-201 Treatment Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study permit geriatric participation?
"This medical study is open to those aged 18 and above, but not exceeding 35 years of age."
Answered by AI
Are recruitment efforts underway for this research endeavor?
"Clinicaltrials.gov confirms that this trial, which was published on the 1st of January 2023 and last updated on November 15th 2022, is not enrolling patients at present. However, there are over 1250 other studies actively seeking participants to join their trials."
Answered by AI
What are the eligibility requirements for participating in this clinical research?
"This clinical trial seeks 18 individuals, aged between eighteen and thirty-five years old, to participate that have been recently diagnosed with Type 1 diabetes. The prospective patients must be physically fit, mentally sound and willing to adhere to the stipulations of the study protocol. They are required to provide informed consent as well as prove a negative pregnancy test where applicable; additionally all reproductive age participants need to use two effective methods of birth control for the duration of their involvement in the study. Furthermore potential subjects should possess adequate venous access for necessary blood draws."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Diabetes Research Institute, University of Miami Miller School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
2
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