Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Study Overview
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Brief Summary
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The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.

Detailed Description
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This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.

Official Title
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Linagliptin and Mesenchymal Stem Cells: A Pilot Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Linagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia. Considered clinically stable, and on the same dose of antipsychotic for two weeks. A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item. Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine. Age 18-45 years. Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays. Exclusion Criteria: Does not meet DSM criteria for substance abuse or dependence. No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Linagliptin patients with schizophrenia<br>This group will be made up of 8 participants with schizophrenia and minimal thought disorder who have been stable and taking their prescribed antipsychotics; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. | Drug: Linagliptin<br>* 12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.<br>* Other names: Tradjenta;|
| Active Comparator: Linagliptin control group<br>This group will be made up of 10 control participants with no diagnosis of mental disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day. | Drug: Linagliptin<br>* 12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.<br>* Other names: Tradjenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDF1-α (stromal cell-derived factor alpha) Concentration |  | Blood will be collected on the first week and then biweekly for 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DPP-4 (Dipeptidyl peptidase-4) Activity |  | Blood will be collected on the first week and then biweekly for 12 weeks. | 
| Monocyte State | Flow cytometry will be used to examine the state of monocytes to look for cells recently arrived from the bone marrow and to examine the polarization (pro-inflammatory vs. anti-inflammatory) of the monocytes | Blood will be collected on the first week and then biweekly for 12 weeks. | 
| Absolute/Differential leukocyte count | Flow cytometry will be used. | Blood will be collected on the first week and then biweekly for 12 weeks. | 
| CD271+ cells | Flow cytometry will be used to detect CD271+ cells. | Blood will be collected on the first week and then biweekly for 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DPP-4 Inhibitor, Linagliptin, SDF1-α