Development of an Innovative Method to Extract Cord Blood Stem Cells With High Efficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Umbilical cord blood collection.
- Who it may be relevant to
- Registry conditions: HSCs Extraction. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Umbilical cord blood collection
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.
Primary outcome measures
- Efficacy of HSCs extraction [Time frame: up to 24 months]
Secondary outcome measures (2)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia
Identifiers
NCT: NCT07468201 · HSCs from umbilical cord blood