Development of an Innovative Method to Extract Cord Blood Stem Cells With High Efficiency

March 11, 2026 updated by: Arsenio Spinillo, Fondazione IRCCS Policlinico San Matteo di Pavia
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy women who have signed the informed consent for umbilical cord donation for research purposes.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of ozone treatment on the viability/yield of HSCs.
Time Frame: up to 24 months
The potential of ozone treatment to stimulate cells proliferation will be assessed
up to 24 months
cells recovery after freezing and thawing
Time Frame: up to 24 months
Vitality (number of cells) by trypan blue staining and cell counting.
up to 24 months

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

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 (Actual)

April 10, 2024

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HSCs from umbilical cord blood

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.

Clinical Trials on HSCs Extraction

Clinical Trials on Umbilical cord blood collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe