Clinical trial NCT05308836: Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Official title: Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Diabetes Adipose-derived mesenchymal stem cell
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
Collaborators: name: Gwoxi Stem cell applied technology Company
First posted: 2022-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety measure
timeFrame: up to the 6-month period following treatment
Secondary outcomes:
measure: HbA1c
timeFrame: up to the 6-month period following treatment
measure: Fasting blood glucose (FPG)
timeFrame: up to the 6-month period following treatment
measure: C-peptide levels
timeFrame: up to the 6-month period following treatment
measure: Blood insulin
timeFrame: up to the 6-month period following treatment
measure: Insulin dose
timeFrame: up to the 6-month period following treatment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem T Nguyen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Chen W, Feng B, Cao H. The Clinical Efficacy and Safety of Stem Cell Therapy for Diabetes Mellitus: A Systematic Review and Meta-Analysis. Aging Dis. 2020 Feb 1;11(1):141-153. doi: 10.14336/AD.2019.0421. eCollection 2020 Feb.
citation: Araujo DB, Dantas JR, Silva KR, Souto DL, Pereira MFC, Moreira JP, Luiz RR, Claudio-Da-Silva CS, Gabbay MAL, Dib SA, Couri CEB, Maiolino A, Rebelatto CLK, Daga DR, Senegaglia AC, Brofman PRS, Baptista LS, Oliveira JEP, Zajdenverg L, Rodacki M. Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study. Front Immunol. 2020 Jun 2;11:993. doi: 10.3389/fimmu.2020.00993. eCollection 2020.