HSCs ExtractionNCT07468201
Development of an Innovative Method to Extract Cord Blood Stem Cells With High Efficiency
An observational study of HSCs Extraction, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The present study has the purpose to develop an innovative method for obtaining HSCs with a high yield. HSCs extracted from UCB using the traditional method followed by several steps of centrifugation will be compared to the new method which exploit a new biocompatible liquid, capable to separate the HSCs without… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HSCs Extraction
- What is being tested?
- Umbilical cord blood collection
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2024to 10 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy women who have signed the informed consent for umbilical cord donation for research purposes.
Who may be able to join
- Healthy women who have signed the informed consent for umbilical cord donation for research purposes
Who cannot join
- Women with inability to comply with the requirements of the protocol and presence of viral infections.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Arsenio Spinillo, MD, 0382503792, a.spinillo@smatteo.pv.it
About this study
The present study has the purpose to develop an innovative method for obtaining HSCs with a high yield. HSCs extracted from UCB using the traditional method followed by several steps of centrifugation will be compared to the new method which exploit a new biocompatible liquid, capable to separate the HSCs without causing mechanical stress to cells. The potential of ozone treatment to stimulate cells proliferation will be also assessed. Since ozone has been identified as an adjuvant to sustain cytoprotective pathways increasing cell performance, HSCs obtained from UCB samples will be treated by flowing ozone at low concentrations (between 2 and 20 μg/mL) in a mixture 1:1 with oxygen.
- Conditions
- HSCs Extraction
- Being tested
- Umbilical cord blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood collectionOther
the study purpose is to collect between 70 to 200 ml of blood for each donor from both caesarean and natural births, post-partum. The umbilical cord will be clamped, as directed by the surgeon performing the procedure, in two places: close to the placenta and close to the baby.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HSCs extraction
Evaluation of the efficacy of HSCs extraction with a new method which exploit a new biocompatible liquid, capable to separate the HSCs without causing mechanical stress to cells.
Measured: up to 24 months
Secondary outcomes (2)
Effect of ozone treatment on the viability/yield of HSCs.
The potential of ozone treatment to stimulate cells proliferation will be assessed
Measured: up to 24 months
cells recovery after freezing and thawing
Vitality (number of cells) by trypan blue staining and cell counting.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 Apr 2024
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCs ExtractionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsenio Spinillo, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468201
- Sponsor's protocol ID
- HSCs from umbilical cord blood
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Innovative Method to Extract Cord Blood Stem Cells With High Efficiency
- ClinicalTrials.gov ID
- NCT07468201
- Acronym / sponsor ID
- HSCs from umbilical cord blood
- Conditions
- HSCs Extraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
The present study has the purpose to develop an innovative method for obtaining HSCs with a high yield. HSCs extracted from UCB using the traditional method followed by several steps of centrifugation will be compared to the new method which exploit a new biocompatible liquid, capable to separate the HSCs without causing mechanical stress to cells. The potential of ozone treatment to stimulate cells proliferation will be also assessed. Since ozone has been identified as an adjuvant to sustain cytoprotective pathways increasing cell performance, HSCs obtained from UCB samples will be treated by flowing ozone at low concentrations (between 2 and 20 μg/mL) in a mixture 1:1 with oxygen.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy women who have signed the informed consent for umbilical cord donation for research purposes.
Key inclusion criteria (1 listed)
- Healthy women who have signed the informed consent for umbilical cord donation for research purposes
Key exclusion criteria (1 listed)
- Women with inability to comply with the requirements of the protocol and presence of viral infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood collectionthe study purpose is to collect between 70 to 200 ml of blood for each donor from both caesarean and natural births, post-partum. The umbilical cord will be clamped, as directed by the surgeon performing the procedure, in two places: close to the placenta and close to the baby. | Other | – |
Primary outcome
Efficacy of HSCs extraction
Time frame: up to 24 months
Evaluation of the efficacy of HSCs extraction with a new method which exploit a new biocompatible liquid, capable to separate the HSCs without causing mechanical stress to cells.
2 secondary outcomes
Effect of ozone treatment on the viability/yield of HSCs.
Time frame: up to 24 months
cells recovery after freezing and thawing
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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.
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 HSCs Extraction, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Mar 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsenio Spinillo, MD (0382503792, a.spinillo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HSCs extraction (time frame: up to 24 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 12 Mar 2026.