HSCs Extraction
Conditions
Brief 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 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
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.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of HSCs extraction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ozone treatment on the viability/yield of HSCs. | up to 24 months | The potential of ozone treatment to stimulate cells proliferation will be assessed |
| cells recovery after freezing and thawing | up to 24 months | Vitality (number of cells) by trypan blue staining and cell counting. |
Countries
Italy
Contacts
CONTACTArsenio Spinillo, MD
Outcome results
None listed