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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes

Treatments

Combination Product: adipose-derived messenchymal stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT05308836

ISC20.01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in patients with type 1 diabetes mellitus (T1D)

Full description

Adipose derived mesenchymal stem cells (AD-MSCs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in treatment 10 patients with type 1 diabetes mellitus (T1D) at Vinmec International Hospital, Hanoi, Vietnam.

Enrollment

10 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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