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

Sponsor
Andrews Research & Education Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05573412
Collaborator
Florida (Other)
100
Enrollment
1
Location
12
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Cellular analysis

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Comparison of the Proliferative Potential of Human Peripheral Blood Stem Cells Based on Demographic Factors and Cryopreservation Time
Actual Study Start Date :
Aug 16, 2022
Anticipated Primary Completion Date :
Aug 16, 2023
Anticipated Study Completion Date :
Aug 16, 2023

Arms and Interventions

Arm Intervention/Treatment
All Particpants

Group contains all participants as this is a systemic review of stem cell cryopreservation techniques

Other: Cellular analysis
Previously cryopreserved samples will be analyzed for total nucleated cell count (TNC), cell viability and proliferative potential

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andrews Research & Education Foundation Gulf Breeze Florida United States 32561

Sponsors and Collaborators

  • Andrews Research & Education Foundation
  • Florida

Investigators

  • Principal Investigator: Adam Anz, MD, Orthopedic Surgeon

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andrews Research & Education Foundation
ClinicalTrials.gov Identifier:
NCT05573412
Other Study ID Numbers:
  • PBSC
First Posted:
Oct 10, 2022
Last Update Posted:
Oct 10, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 10, 2022