Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time

Recruiting

• Conditions: Healthy
• Interventions: Other: Cellular analysis

• Registration Number: NCT05573412
• Lead Sponsor: Andrews Research & Education Foundation

Brief Summary

The goal of this observational study is to observe stored stem cells and determine their capability to grow based on several factors. The main two factors focused on in this study are as follows:

* Time stem cells have spent in cryopreservation

* Demographic factors (gender, race, age)

Detailed Description

This study is a secondary, correlational, single-center laboratory study involving the analysis of previously obtained PBSC samples at the Andrews Research \& Education Foundation (AREF). Individuals who previously provided samples for a primary study that has a concluded will be reconsented for this study. No manipulation of samples will occur until Broad Informed Consent has been obtained. Upon Broad Informed Consent being granted, the samples will be removed from cryopreservation and analyzed in a laboratory setting.

Each sample's total nucleated cell count (TNC), cell viability, and proliferative potential will be analyzed. Measurements will be performed at different time intervals and the results will be recorded in a password protected system.

These parameters will be followed for each available PBSC sample regardless of time spent in cryopreservation to examine if variation in time spent under cryopreservation had an impact on overall cell viability and proliferative potential.

Following conclusion of the cell viability data acquisition stage of the study, the data will be further analyzed to determine if there are any statistically relevant correlations between various demographic factors and the viabilities of the PBSC samples. The secondary, demographic factors to be examined include the sample patient's age, sex, and race. The data analysis will determine whether these factors in addition to length of time spent under cryopreservation influenced the PBSC samples' viability and proliferative potential upon the samples being removed from cryopreservation and prepared for analysis.

Study Timeline

• Study Start: 2022-08-16
• Status Verified: 2022-10
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years of age or older
• Prior primary study at Andrews Research & Education Foundation must be completed
• Additional biospecimens continue to be in a cryopreserved state at Andrews Research & Education Foundation Regenerative Medicine Center (RMC)
• Subject is willing and able to provide Broad Informed Consent for secondary study

Exclusion Criteria

• Subjects whose biospecimens did not maintain primary study sample labels
• Subject is not willing and able to provide Broad Informed Consent for secondary study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Particpants	Cellular analysis	Group contains all participants as this is a systemic review of stem cell cryopreservation techniques

Primary Outcome Measures

Name	Time	Method
Beckman-Coulter Flow Cytometer	At enrollment	Machine that provides a digital view of cells that are categorized utilizing laser light to differentiate cell types while samples are suspended in a fast-flowing liquid; will be utilized to determine proliferative potential, total nucleated cell count, and cell viability of each cryopreserved sample

Trial Locations

Locations (1)

Andrews Research & Education Foundation; 🇺🇸 Gulf Breeze, Florida, United States