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

October 6, 2022 updated by: Andrews Research & Education Foundation

Comparison of the Proliferative Potential of Human Peripheral Blood Stem Cells Based on Demographic Factors and Cryopreservation Time

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • Andrews Research & Education Foundation
        • Sub-Investigator:
          • Adam Anz, MD
        • Sub-Investigator:
          • Steve Jordan, MD
        • Contact:
        • Principal Investigator:
          • James Andrews, MD
        • Sub-Investigator:
          • Roger Ostrander, MD
        • Sub-Investigator:
          • Christopher O'Grady, MD
        • Sub-Investigator:
          • Charles Roth, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beckman-Coulter Flow Cytometer
Time Frame: 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
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Anticipated)

August 16, 2023

Study Completion (Anticipated)

August 16, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PBSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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