Health TrialsbyHealthPanel

cfMSC Therapy for Diabetes

ConditionType II Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand the study protocol and voluntarily sign the written informed consent form;

A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months);

Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;

Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;

Disqualifiers

Type 1 diabetes mellitus or other special types of diabetes;

Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;

A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;

HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;

Trial design

Design model

Single group

Treatments tested in this trial

  • cfMSC therapy for diabetes

    Biological/Vaccine

    Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitusExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with adverse events.

Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
24 weeks

Secondary outcomes

1

Change of glycated hemoglobin (HbA1c) level.

Evaluate the improvement of long-term blood glucose control in patients, with the primary observation of the change range of HbA1c from baseline to 12 and 24 months after treatment.

Time frame
24 months
2

Change of daily C-peptide level.

Detect the fasting and postprandial C-peptide levels to evaluate the recovery of endogenous insulin secretion function.

Time frame
24 months
3

Change of daily exogenous insulin dosage.

Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction.

Time frame
24 months
4

Proportion of patients achieving insulin independence.

Statistically analyze the number and proportion of patients who achieve complete or partial insulin independence after treatment and maintain the state for more than 6 months.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: