Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

Plain-language summary

This study evaluates the safety of transplanting adipose (fat)-derived mesenchymal stem cells for the treatment of type 1 diabetes. It enrolled patients aged 5 and over who had been diagnosed with type 1 diabetes within the previous 12 months. The study was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Intervention

adipose-derived messenchymal stem cell

Start date

5/4/2021

Estimated completion

12/30/2024

Countries

Vietnam

Related genes

Locations

• Hanoi, Vietnam

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)
* Aged from 5 years and over.
* The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
* Blood testing conducted at the time of diagnosis:

  * Fasting blood glucose ≥ 7 mmol / L,
  * HbA1C ≥ 6.5%.
  * Have at least one antibodies associated with T1D such as ICA; GAD; ZnT8 or IAA.
* At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.
* The patient does not have other serious acute illness requiring treatment
* The patient agrees to use stem cell transplant for treatment
* The patient's parent (parent or legal guardian) can read, write, understand the ICF form and agree to sign a consent to participate in the study.

Exclusion Criteria:

* Having evidence related to renal dysfunction: creatinine \> 1.5 mg/dl or (\>133 mmol/L) for boys, creatinine \> 1.4 mg/dl or (\>124 mmol/L) for girls
* In case of kidney failure. Proteinuria within the range of nephrotic syndrome (\>3.5 g/day or ratio of protein/creatinine in urine \>2.7)
* In case of kidney failure
* Having severe infection or infected with hepatitis B virus, hepatitis C virus, HIV virus, or tuberculosis
* Cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease
* Blood clotting disorders (INR\> 1,5, PTT\> 40, PT\> 15).
* Taking any anticoagulant
* Taking systemic steroids
* Participate in another clinical study involving experimenting drugs and/or medical equipment
* History of allergic reaction to anesthetic agents and/or antibiotics