NCT00807651

Brief Summary

This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 6 months. The study is evaluating whether stem cell transplantation is safe when chemotherapy and immunotherapy are used in combination and if it has immune resetting effect that may halt the immune attack to pancreas islets and thus preserve the body's own insulin production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

8.3 years

First QC Date

December 11, 2008

Last Update Submit

November 16, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes MellitusStem cellsAutologous stem cell transplantationAutoimmune diseases

Outcome Measures

Primary Outcomes (1)

  • Exogenous insulin dose

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months

Secondary Outcomes (3)

  • Anti-GAD titres

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months

  • C-peptide level

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months

  • HbA1c level

    3 months, 6 months, 12 months, 24 months, 36 months

Study Arms (2)

insulin therapy

ACTIVE COMPARATOR

The participants not accepted written informed consent will receive insulin therapy

Drug: Insulin therapy

AHSCT

EXPERIMENTAL

The participants accepted written informed consent will receive the therapy of autologous hematopoietic stem cell transplantation(AHSCT)

Procedure: AHSCT

Interventions

AHSCTPROCEDURE

All study participants given written informed consent will perform autologous hematopoietic stem cell transplantation(AHSCT) and be treated with immunosuppression.

Also known as: hematopoietic stem cell
AHSCT
Insulin therapyDRUG

All study participants not accepted written informed consent will received insulin therapy with consistent or multiply subcutaneous injection.

Also known as: insulin injection therapy
insulin therapy

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibody
  • Less than 6 months from diagnosis

You may not qualify if:

  • Previous diabetic ketoacidosis
  • Pregnancy
  • Severe psychiatric disorder
  • Severe organic impairment (renal, hepatic, cardiac, pulmonary)
  • Active infectious disease
  • Previous or present neoplastic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (4)

  • Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.

    PMID: 17426276BACKGROUND

  • Ye L, Li L, Wan B, Yang M, Hong J, Gu W, Wang W, Ning G. Immune response after autologous hematopoietic stem cell transplantation in type 1 diabetes mellitus. Stem Cell Res Ther. 2017 Apr 18;8(1):90. doi: 10.1186/s13287-017-0542-1.

    PMID: 28420440DERIVED

  • Gu W, Hu J, Wang W, Li L, Tang W, Sun S, Cui W, Ye L, Zhang Y, Hong J, Zhu D, Ning G. Diabetic ketoacidosis at diagnosis influences complete remission after treatment with hematopoietic stem cell transplantation in adolescents with type 1 diabetes. Diabetes Care. 2012 Jul;35(7):1413-9. doi: 10.2337/dc11-2161.

    PMID: 22723579DERIVED

  • Zhang X, Ye L, Hu J, Tang W, Liu R, Yang M, Hong J, Wang W, Ning G, Gu W. Acute response of peripheral blood cell to autologous hematopoietic stem cell transplantation in type 1 diabetic patient. PLoS One. 2012;7(2):e31887. doi: 10.1371/journal.pone.0031887. Epub 2012 Feb 22.

    PMID: 22384093DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusAutoimmune Diseases

Interventions

Convulsive Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychiatric Somatic TherapiesBehavioral Disciplines and Activities

Study Officials

  • Guang Ning, MD. PhD.

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

CN(1)