Clinical trial NCT02893306: MSC Administration for the Management of Type 1 Diabetic Patients
Official title: Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Type1 Diabetes Mellitus
Multipotent stromal cell
Mesenchymal stem cell
Insulin
Pancreatic reserve
Disease progression
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Clinica Alemana de Santiago
First posted: 2016-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in insulin pancreatic reserve
timeFrame: pre- and 1, 6, 24 months post-intervention
Secondary outcomes:
measure: Changes in insulin requirement
timeFrame: pre- and up to 24 months post-intervention
Other outcomes:
measure: Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)
timeFrame: up to 24 months post-intervention
measure: Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)
timeFrame: up to 24 months post-intervention
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
Study officials:
affiliation: Universidad del Desarrollo
name: Paulette Conget, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Alemana de Santiago
name: Claudio Mizon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.