NCT05308836CompletedPhase 1
Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 25 Feb 2022
- Start date
- 4 May 2021
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Diseases
- Type 1 diabetes
- NCT number
- NCT05308836
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 4 May 2021 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking systemic steroids
- Participate in another clinical study involving experimenting drugs and/or medical equipment
Other illness
- 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
- History of allergic reaction to anesthetic agents and/or antibiotics
Lab values
- 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)
- Blood clotting disorders (INR\> 1,5, PTT\> 40, PT\> 15).
Other
- Taking any anticoagulant
Who the study is looking for
- 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.
Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.