MSC Administration for the Management of Type 1 Diabetic Patients

Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02893306

Acronym

DMT1-MSC

Enrollment

Registered

2016-09-08

Start date

2012-03-31

Completion date

2017-03-31

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type1 Diabetes Mellitus, Multipotent stromal cell, Mesenchymal stem cell, Insulin, Pancreatic reserve, Disease progression

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.

Detailed description

Aim: to evaluate whether a single intravenous administration of allogeneic bone marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified endogenous insulin secretion capacity and exogenous insulin requirement in patients with Type 1 Diabetes Mellitus. Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with pancreatic reserve of insulin. Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic MSCs. Follow up: before and 1, 6, 24 months after MSC administration.

Interventions

BIOLOGICALMSCs

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in insulin pancreatic reserve	pre- and 1, 6, 24 months post-intervention	Levels of insulin secreted after the acute ingestion of a protein rich liquid diet

Secondary

Measure	Time frame	Description
Changes in insulin requirement	pre- and up to 24 months post-intervention	Daily dose of self-administered insulin

Other

Measure	Time frame	Description
Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)	up to 24 months post-intervention	Review of patient clinical records

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026