Caesarean DeliveryReGAINNCT06866184
Regenerative Effects of Birth Material Derived Extracellular Vesicles
An observational study of Caesarean Delivery, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Delivery
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to Jan 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy females undergoing a planned C/S for a single neonate (full term)
Who may be able to join
- • 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Caesarean Delivery
- Keywords
- child birth, caesarean section, healthy donor, umbilical cord, placenta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Expectant healthy females undergoing a planned Caesarean Section (full term) | Expectant healthy females undergoing a planned Caesarean Section (full term) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures
- Isolate and grow MSCs from different components of the birth material, such as the chorion, placenta, amniotic fluid, and the umbilical cord.
- Collect extracellular vesicles from these different sources of MSCs.
- Characterise MSC and EV properties using techniques like microscopy, flow cytometry and ELISAs.
- Compare the functions and characteristics of these extracellular vesicles in models of the ageing brain.
Measured: From enrolment before Caesarean section to tissue analyses within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Oct 2026 (estimated)
- Primary completion7 Jul 2027 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: delay in project planning
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Platt, PhD, Principal investigator, Chair in Translational Neuroscience·BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866184
- Sponsor's protocol ID
- 2-073-23
- Other IDs
- IRAS project ID: 331602
- Acronym
- ReGAIN
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: results will be published and can be shared post publication
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Effects of Young Immortalized and Engineered MSC-Derived EVs on Aging and Senescent Brain Models
- ClinicalTrials.gov ID
- NCT06866184
- Acronym / sponsor ID
- ReGAIN / 2-073-23
- Conditions
- Caesarean Delivery
- Keywords
- child birth, caesarean section, healthy donor, umbilical cord, placenta
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: delay in project planning
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expectant healthy females undergoing a planned Caesarean Section (full term) | – | –Expectant healthy females undergoing a planned Caesarean Section (full term) |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy females undergoing a planned C/S for a single neonate (full term)
Key inclusion criteria (5 listed)
- • Women aged 16 years and older with a good understanding of English
Key exclusion criteria (7 listed)
- • Significant pregnancy complications or abnormal ultrasound scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided. results will be published and can be shared post publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Platt, PhD principal investigator
Chair in Translational Neuroscience·BioSciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Delivery, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures (time frame: From enrolment before Caesarean section to tissue analyses within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.