NCT03484741

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

March 16, 2018

Last Update Submit

April 2, 2018

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Fasting blood glucose

    Assess the changes in fasting blood glucose level after transplantation

    every month in the course of 6 months

  • Hemoglobin A1c (HbA1c) level

    Assess the changes in HbA1C level after transplantation

    1 month, 3 months and 6 months after transplantation

  • Adverse events

    Evaluate the safety of therapy by number record of adverse events (AEs)

    during the course of 6 months

Secondary Outcomes (3)

  • Insulin dose

    during the course of 6 months

  • C-peptide

    every month in the course of 6 months

  • Blood insulin level

    every month in the course of 6 months

Study Arms (1)

MSC and PRP

EXPERIMENTAL

15 patients will be given autologous bone marrow-derived mesenchymal stem cells (BM-MSC) and mesenchymal stem cell from allogeneic umbilical cord tissue (UC-MSC) combined with platelet-rich plasma (PRP) by intravenous infusion.

Biological: MSC and PRP

Interventions

MSC and PRPBIOLOGICAL

MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.

MSC and PRP

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:
  • At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD.
  • Previously diagnosed at a medical facility with Type 1 Diabetes.
  • Having evidence of insulin depletion based on the test results during screening.
  • Patients treated with fixed insulin dose for at least 3 months.
  • Males and females between age 18 and 45 years at the screening.
  • Patients able to read, write and understand ICF form

You may not qualify if:

  • Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
  • Having evidence related to renal dysfunction:
  • creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men.
  • creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman.
  • eGRF \< 40 ml/ min
  • Proteinuria \> 300 mg/day
  • Having evidence of ketoacidosis at the time of selection.
  • Having evidence of ongoing or frequent hypoglycemia.
  • Having severe infection
  • Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs.
  • Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism.
  • Having abnormalities in red blood cells such as sickle cells disease.
  • Using alcohol and/or tobacco.
  • Blood clotting disorders (INR \> 1.5, PTT \>40, PT \> 15).
  • Taking any anticoagulant.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Hanh Geral Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Phuong Le, MSc-MD

    Stem Cell Unit, Van Hanh General Hospital

    PRINCIPAL INVESTIGATOR

  • Ngoc Phan, MSc

    Stem Cell Institute, University of Science Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuong Le, MSc-MD

CONTACT

(+84)902742732drbphuong@gmail.com

Stem Cell Unit, Van Hanh General Hospital

CONTACT

tebaogocvanhanh@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

April 2, 2018

Study Start

April 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 months after publication
Access Criteria
Type 1 Diabetes Mellitus

Locations

VN(1)