Patient-derived Stem Cell Models of Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— ANSTEM  

Official title:

Generation and Analysis of Patient-derived Stem Cell Models of Hypothalamic Neurons and Microglia in Anorexia Nervosa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06259500
• Other study ID #: 2019 00170
• Status: Active, not recruiting
• Start date: August 25, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria anorexia nervosa:

• female
• 18-45 years of age
• AN restrictive diagnosis as main diagnosis
• more than 5 years duration Exclusion Criteria anorexia nervosa: -

Inclusion Criteria healthy control:

• female
• 18-45 years of age
• BMI 18,5 - 25

Exclusion Criteria healthy control:

• own or family member with eating disorder diagnosis
• own or family member with autism diagnosis

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• observational
Profiling the function of iPSC derived Arcuate neurons and PBMC derived microglia

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microglia function and transcriptomic profiling	phagocytic and immune activation capacity and whole transcriptomic profiling, anorexia nervosa vs healthy controls	2025
Primary	Arcuate neuron function and transcriptomic profiling	Electrical activity, transmitter release and whole transcriptomic profiling of iPSC derived Arcuate neurons, anorexia nervosa vs healthy controls	2026