Clinical trial NCT05573412: Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time
Official title: Comparison of the Proliferative Potential of Human Peripheral Blood Stem Cells Based on Demographic Factors and Cryopreservation Time
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2022-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The target study population for this study is patients of any gender (age 18 or above) that has already completed a study at Andrews Research \& Education Foundation and has cryopreserved blood samples at the Andrews Research \& Education Foundation Regenerative Medicine Center (RMC)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beckman-Coulter Flow Cytometer
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
Study officials:
affiliation: Orthopedic Surgeon
name: Adam Anz, MD
role: PRINCIPAL_INVESTIGATOR
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