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CRG002

Phase 1

T1DM - Type 1 Diabetes Mellitus | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

CRG002 · 1 trial · 2 indications

Early Phase 1 1
NCT07503028An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic EventsT1DM - Type 1 Diabetes Mellitus
ENROLLING BY_INVITATION10 Analytics
EARLY_PHASE1ENROLLING BY_INVITATION
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
T1DM - Type 1 Diabetes Mellitus
NCT0750302810
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Study Endpoints

Primary Endpoints

Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
Within one year after CRG-002 transplantation

Number of adverse events as assessed by CTCAE v6.0，including Adverse Events of Special Interest (AESI), Treatment-Related Adverse Events (TEAE), Treatment-Related Adverse Events (TRAE), and Procedure-Related Adverse Events (PRAE); Serious Adverse Events (SAE), Treatment-Related Serious Adverse Events (TRSAE), and Procedure-Related Serious Adverse Events (PRAE)

Secondary Endpoints

Daily insulin dosage of subjects
Within one year after CRG-002 transplantation
Time to subjects achieving insulin independence.
Within one year after CRG-002 transplantation
Numbers of subjects achieving insulin independence.
Within one year after CRG-002 transplantation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental groupEXPERIMENTALCRG002

Interventions

NameTypeDescription
CRG002DRUGIntraportal infusion or Implantation underneath the abdominal anterior rectus sheat
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18-70 years, any gender. 2. Long-standing type 1 diabetes or pancreatic diabetes. 3. Significant pancreatic islet dysfunction. 4. Hemoglobin A1c within clinically acceptable range. 5. At least 1 hypoglycemic event requiring external intervention within 12 months. 6. Able ...

Countries:China
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