High-yield method for extracting hematopoietic stem cells from cord blood
Development of an Innovative Method to Extract Cord Blood Stem Cells With High Efficiency
This research tests whether a new biocompatible liquid, with or without low-dose ozone treatment, can extract more viable hematopoietic stem cells from donated umbilical cord blood than standard centrifugation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07468201 on ClinicalTrials.gov |
What this trial studies
The project compares traditional centrifugation-based extraction of hematopoietic stem cells (HSCs) from umbilical cord blood with a novel separation technique that uses a biocompatible liquid designed to reduce mechanical stress on cells. Collected cord blood samples will be split and processed by both methods, and some samples will receive low-concentration ozone (2–20 μg/mL, mixed 1:1 with oxygen) to test effects on cell proliferation. Outcomes will include HSC yield, viability, and short-term proliferation metrics measured in the laboratory. All donations are from consenting healthy women and the work is conducted at a single center in Pavia, Lombardy.
Who should consider this trial
Good fit: Healthy women who sign informed consent to donate their newborn's umbilical cord blood for research at the participating hospital.
Not a fit: Women with active viral infections or those unable to comply with protocol requirements are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the method could increase the number and quality of HSCs obtainable from a single cord blood unit, improving availability for transplants and research.
How similar studies have performed: Mechanical and density-based approaches have previously improved cord blood HSC recovery, but the combination of a biocompatible separating liquid and low-dose ozone is relatively novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women who have signed the informed consent for umbilical cord donation for research purposes Exclusion Criteria: * Women with inability to comply with the requirements of the protocol and presence of viral infections.
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Arsenio Spinillo, MD
- Email: a.spinillo@smatteo.pv.it
- Phone: 0382503792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.