MSC Administration for the Management of Type 1 Diabetic Patients

Type 1 Diabetes Mellitus Clinical Trial

— DMT1-MSC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02893306
• Other study ID #: DMT1-MSC
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 27, 2016
• Last updated: September 1, 2016
• Start date: March 2012
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• MSCs
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

Locations

Country	Name	City	State
Chile	Clinica Alemana de Santiago	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Clinica Alemana de Santiago

Country where clinical trial is conducted

Chile, 

References & 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. — View Citation

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. — View Citation

Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yañez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)	Review of patient clinical records	up to 24 months post-intervention	No
Other	Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)	Regular communication with patient and his/her physician in order to be informed of eventual complications	up to 24 months post-intervention	Yes
Primary	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	No
Secondary	Changes in insulin requirement	Daily dose of self-administered insulin	pre- and up to 24 months post-intervention	No