Regenerative Effects of Birth Material Derived Extracellular Vesicles (ReGAIN)

May 20, 2026 updated by: University of Aberdeen

Regenerative Effects of Young Immortalized and Engineered MSC-Derived EVs on Aging and Senescent Brain Models

Stem cells offer great hope for a wide range of disorders, including age-related brain disease such as dementia. Mesenchymal stem cells (MSCs) are special types of adult stem cells found in various tissues like the umbilical cord, placenta and bone marrow. These cells can develop into different cell types, such as bone, cartilage, muscle, and neurones. They can promote healing, regulate the immune system and repair damaged tissues. Extracellular vesicles (EVs) are tiny, bubble-like structures released by MSCs, which help communication between tissues and organs by delivering specific instructions and regenerative substances. Therefore, MSC-EVs are thought to be responsible for many of beneficial effects.

Recent evidence suggests that specific properties of EVs depend on where the MSCs come from, how old the donor was, and the environment/conditions they are in. To better understand the best source of MSC-EVs for treating age-related brain diseases, the investigators here plan to use placenta, amniotic fluid, and umbilical cord tissues of consenting mothers, who are undergoing an elective Caesarean section. Such birth tissues are rich sources of stem cells and would normally be disposed off. The investigators will here extract and analyse EVs and seek to identify the most effective ones for regenerating aged or damaged brain cells. Once the investigators identify the best source, they will seek to stabilise ("immortalize") the stem cells so that they offer a consistent source of effective MSC-EVs. Additionally, the investigators aim to modify MSCs genetically or via exposure to regenerative compounds to enhance their therapeutic properties. Promising MSC-EVs will be tested on cell culture models of brain aging and disease to validate if they can repair damage or aid recovery.

Overall, the project aims to explore sources and properties of MSC-EVs that may offer new therapeutic ways to treat brain diseases.

Study Overview

Status

Suspended

Conditions

Detailed Description

Stem cells offer great hope for a wide range of disorders, including age-related brain disease such as dementia. Mesenchymal stem cells (MSCs) are special types of adult stem cells found in various tissues like the umbilical cord, placenta and bone marrow. These cells can develop into different cell types, such as bone, cartilage, muscle, and neurones. They can promote healing, regulate the immune system and repair damaged tissues. Extracellular vesicles (EVs) are tiny, bubble-like structures released by MSCs, which help communication between tissues and organs by delivering specific instructions and regenerative substances. Therefore, MSC-EVs are thought to be responsible for many of beneficial effects.

Recent evidence suggests that specific properties of EVs depend on where the MSCs come from, how old the donor was, and the environment/conditions they are in. To better understand the best source of MSC-EVs for treating age-related brain diseases, the investigators here plan to use placenta, amniotic fluid, and umbilical cord tissues of consenting mothers, who are undergoing an elective Caesarean section. Such birth tissues are rich sources of stem cells and would normally be disposed off. The investigators will here extract and analyse EVs and seek to identify the most effective ones for regenerating aged or damaged brain cells. Once the investigators identify the best source, they will seek to stabilise ("immortalize") the stem cells so that they offer a consistent source of effective MSC-EVs. Additionally, the investigators aim to modify MSCs genetically or via exposure to regenerative compounds to enhance their therapeutic properties. Promising MSC-EVs will be tested on cell culture models of brain aging and disease to validate if they can repair damage or aid recovery.

Overall, the project aims to explore sources and properties of MSC-EVs that may offer new therapeutic ways to treat brain diseases.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy females undergoing a planned C/S for a single neonate (full term)

Description

Inclusion Criteria:

  • • Women aged 16 years and older with a good understanding of English

    • Women undergoing a non-emergency elective C/S for a single neonate
    • Pregnancies ≥30 weeks of gestation
    • Taking no regular medication other than pregnancy related vitamins or supplements
    • Participant must be able to give fully informed written consent.

Exclusion Criteria:

  • • Significant pregnancy complications or abnormal ultrasound scans

    • Placenta expected to be sent to pathology following delivery (common reasons for this: baby admitted to neonatal unit, abnormal cord blood pH levels, abruption, peripartum sepsis, or severe growth restriction)
    • Any significant disease or disorder in the mother including the following: autoimmune conditions (Lupus, scleroderma, Hashimoto's, RA, arthritis etc), cancer, diabetes, genetic abnormalities, infection (Hepatitis, HIV, EBV, Herpes, STDs, chronic bacterial), liver or kidney disease, neurological conditions or COVID within past 6 months.
    • Currently part of another CTIMP study.
    • Drugs or smoking during pregnancy, or excessive alcohol consumption.
    • Unable to understand English as no translator will be available for this study.
    • Unable to give fully informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Expectant healthy females undergoing a planned Caesarean Section (full term)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measures
Time Frame: From enrolment before Caesarean section to tissue analyses within 12 months
  1. Isolate and grow MSCs from different components of the birth material, such as the chorion, placenta, amniotic fluid, and the umbilical cord.
  2. Collect extracellular vesicles from these different sources of MSCs.
  3. Characterise MSC and EV properties using techniques like microscopy, flow cytometry and ELISAs.
  4. Compare the functions and characteristics of these extracellular vesicles in models of the ageing brain.
From enrolment before Caesarean section to tissue analyses within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Bettina Platt, PhD, Chair in Translational Neuroscience·BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2-073-23
  • IRAS project ID: 331602 (Other Identifier: The Integrated Research Application System (IRAS), UK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

results will be published and can be shared post publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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