NCT02893306

Brief Summary

The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.

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
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2

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

March 1, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

August 27, 2016

Last Update Submit

September 1, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

Type1 Diabetes MellitusMultipotent stromal cellMesenchymal stem cellInsulinPancreatic reserveDisease progression

Outcome Measures

Primary Outcomes (1)

  • Changes in insulin pancreatic reserve

    Levels of insulin secreted after the acute ingestion of a protein rich liquid diet

    pre- and 1, 6, 24 months post-intervention

Secondary Outcomes (1)

  • Changes in insulin requirement

    pre- and up to 24 months post-intervention

Other Outcomes (2)

  • Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)

    up to 24 months post-intervention

  • Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)

    up to 24 months post-intervention

Study Arms (1)

DMT1+MSCs

EXPERIMENTAL

type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells

Biological: MSCs

Interventions

MSCsBIOLOGICAL

origin: bone marrow of healthy donor; manipulation: ex vivo expanded; via: intravenous; vehicle: 5% human recombinant albumin in physiological serum; dose: 2-3 millions/Kg; dosage: single

Also known as: mesenchymal stem cells
DMT1+MSCs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • differential diagnosis of Type 1 Diabetes
  • diagnosed performed at most 1 year before enrollment
  • pancreatic reserve of insulin higher than 0.8 nmol/L/h
  • good general health status
  • informed consent of patient
  • consent of treating physician
  • proved psychiatric competence to be enrolled in a clinical study

You may not qualify if:

  • pregnancy
  • significant comorbidities
  • HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (3)

  • Ezquer F, Ezquer M, Contador D, Ricca M, Simon V, Conget P. The antidiabetic effect of mesenchymal stem cells is unrelated to their transdifferentiation potential but to their capability to restore Th1/Th2 balance and to modify the pancreatic microenvironment. Stem Cells. 2012 Aug;30(8):1664-74. doi: 10.1002/stem.1132.

    PMID: 22644660BACKGROUND

  • Ezquer F, Ezquer M, Simon V, Conget P. The antidiabetic effect of MSCs is not impaired by insulin prophylaxis and is not improved by a second dose of cells. PLoS One. 2011 Jan 27;6(1):e16566. doi: 10.1371/journal.pone.0016566.

    PMID: 21304603BACKGROUND

  • Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.

    PMID: 18489988BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin ResistanceDisease Progression

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinismDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paulette Conget, PhD

    Universidad del Desarrollo

    PRINCIPAL INVESTIGATOR

  • Claudio Mizon, MD

    Clinica Alemana de Santiago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 8, 2016

Study Start

March 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Data will be publish in a peer review journal

Locations

CL(1)