HealthyNCT05573412
Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time
An observational study of Healthy, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cellular analysis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 16 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Subjects whose biospecimens did not maintain primary study sample labels
- Subject is not willing and able to provide Broad Informed Consent for secondary study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
Jessica Truett, BCBA, 850-916-8570, Jessica.truett@andrewsref.org
James Andrews, MD
About this study
Official title: 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)
Read the 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.
- Conditions
- Healthy
- Being tested
- Cellular analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular analysisOther
Previously cryopreserved samples will be analyzed for total nucleated cell count (TNC), cell viability and proliferative potential
| Study group | Role | What they receive |
|---|---|---|
| All Particpants | Group contains all participants as this is a systemic review of stem cell cryopreservation techniques Receives: Other: Cellular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beckman-Coulter Flow Cytometer
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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Aug 2022
- Primary completion16 Aug 2023 (estimated)
- Study completion16 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
- Investigators
- Adam Anz, MD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573412
- Sponsor's protocol ID
- PBSC
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gratwohl A, Hermans J, Baldomero H. Hematopoietic precursor cell transplants in Europe: activity in 1994. Report from the European Group for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 1996 Feb;17(2):137-48.
PubMed 8640158Korbling M, Freireich EJ. Twenty-five years of peripheral blood stem cell transplantation. Blood. 2011 Jun 16;117(24):6411-6. doi: 10.1182/blood-2010-12-322214. Epub 2011 Apr 1.
PubMed 21460243Schmitz N, Bacigalupo A, Hasenclever D, Nagler A, Gluckman E, Clark P, Bourquelot P, Greinix H, Frickhofen N, Ringden O, Zander A, Apperley JF, Gorin C, Borkett K, Schwab G, Goebel M, Russell NH, Gratwohl A. Allogeneic bone marrow transplantation vs filgrastim-mobilised peripheral blood progenitor cell transplantation in patients with early leukaemia: first results of a randomised multicentre trial of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 1998 May;21(10):995-1003. doi: 10.1038/sj.bmt.1701234.
PubMed 9632272Blaise D, Kuentz M, Fortanier C, Bourhis JH, Milpied N, Sutton L, Jouet JP, Attal M, Bordigoni P, Cahn JY, Boiron JM, Schuller MP, Moatti JP, Michallet M. Randomized trial of bone marrow versus lenograstim-primed blood cell allogeneic transplantation in patients with early-stage leukemia: a report from the Societe Francaise de Greffe de Moelle. J Clin Oncol. 2000 Feb;18(3):537-46. doi: 10.1200/JCO.2000.18.3.537.
PubMed 10653869Cutler C, Antin JH. Peripheral blood stem cells for allogeneic transplantation: a review. Stem Cells. 2001;19(2):108-17. doi: 10.1634/stemcells.19-2-108.
PubMed 11239165Nehrer S, Spector M, Minas T. Histologic analysis of tissue after failed cartilage repair procedures. Clin Orthop Relat Res. 1999 Aug;(365):149-62. doi: 10.1097/00003086-199908000-00020.
PubMed 10627699Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20. doi: 10.2106/JBJS.D.02846.
PubMed 16140804Minas T, Ogura T, Bryant T. Autologous Chondrocyte Implantation. JBJS Essent Surg Tech. 2016 Jun 22;6(2):e24. doi: 10.2106/JBJS.ST.16.00018. eCollection 2016 Jun 22.
PubMed 30237933Fortier LA, Potter HG, Rickey EJ, Schnabel LV, Foo LF, Chong LR, Stokol T, Cheetham J, Nixon AJ. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. J Bone Joint Surg Am. 2010 Aug 18;92(10):1927-37. doi: 10.2106/JBJS.I.01284.
PubMed 20720135Lee KB, Hui JH, Song IC, Ardany L, Lee EH. Injectable mesenchymal stem cell therapy for large cartilage defects--a porcine model. Stem Cells. 2007 Nov;25(11):2964-71. doi: 10.1634/stemcells.2006-0311. Epub 2007 Jul 26.
PubMed 17656639McIlwraith CW, Frisbie DD, Rodkey WG, Kisiday JD, Werpy NM, Kawcak CE, Steadman JR. Evaluation of intra-articular mesenchymal stem cells to augment healing of microfractured chondral defects. Arthroscopy. 2011 Nov;27(11):1552-61. doi: 10.1016/j.arthro.2011.06.002. Epub 2011 Aug 20.
PubMed 21862278Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.
PubMed 20392971Tay LX, Ahmad RE, Dashtdar H, Tay KW, Masjuddin T, Ab-Rahim S, Chong PP, Selvaratnam L, Kamarul T. Treatment outcomes of alginate-embedded allogenic mesenchymal stem cells versus autologous chondrocytes for the repair of focal articular cartilage defects in a rabbit model. Am J Sports Med. 2012 Jan;40(1):83-90. doi: 10.1177/0363546511420819. Epub 2011 Sep 13.
PubMed 21917609Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.
PubMed 8150826Saw KY, Hussin P, Loke SC, Azam M, Chen HC, Tay YG, Low S, Wallin KL, Ragavanaidu K. Articular cartilage regeneration with autologous marrow aspirate and hyaluronic Acid: an experimental study in a goat model. Arthroscopy. 2009 Dec;25(12):1391-400. doi: 10.1016/j.arthro.2009.07.011. Epub 2009 Sep 17.
PubMed 19962065
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Proliferative Potential of Human Peripheral Blood Stem Cells Based on Demographic Factors and Cryopreservation Time
- ClinicalTrials.gov ID
- NCT05573412
- Acronym / sponsor ID
- PBSC
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Aug 2023 (estimated)
- Study completion
- 16 Aug 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Particpants | – | Other: Cellular analysisGroup contains all participants as this is a systemic review of stem cell cryopreservation techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects whose biospecimens did not maintain primary study sample labels
- Subject is not willing and able to provide Broad Informed Consent for secondary study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellular analysisPreviously cryopreserved samples will be analyzed for total nucleated cell count (TNC), cell viability and proliferative potential | Other | All Particpants |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 8640158Gratwohl A, Hermans J, Baldomero H. Hematopoietic precursor cell transplants in Europe: activity in 1994. Report from the European Group for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 1996 Feb;17(2):137-48.
- Background: PubMed 21460243Korbling M, Freireich EJ. Twenty-five years of peripheral blood stem cell transplantation. Blood. 2011 Jun 16;117(24):6411-6. doi: 10.1182/blood-2010-12-322214. Epub 2011 Apr 1.
- Background: PubMed 9632272Schmitz N, Bacigalupo A, Hasenclever D, Nagler A, Gluckman E, Clark P, Bourquelot P, Greinix H, Frickhofen N, Ringden O, Zander A, Apperley JF, Gorin C, Borkett K, Schwab G, Goebel M, Russell NH, Gratwohl A. Allogeneic bone marrow transplantation vs filgrastim-mobilised peripheral blood progenitor cell transplantation in patients with early leukaemia: first results of a randomised multicentre trial of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 1998 May;21(10):995-1003. doi: 10.1038/sj.bmt.1701234.
- Background: PubMed 10653869Blaise D, Kuentz M, Fortanier C, Bourhis JH, Milpied N, Sutton L, Jouet JP, Attal M, Bordigoni P, Cahn JY, Boiron JM, Schuller MP, Moatti JP, Michallet M. Randomized trial of bone marrow versus lenograstim-primed blood cell allogeneic transplantation in patients with early-stage leukemia: a report from the Societe Francaise de Greffe de Moelle. J Clin Oncol. 2000 Feb;18(3):537-46. doi: 10.1200/JCO.2000.18.3.537.
- Background: PubMed 11239165Cutler C, Antin JH. Peripheral blood stem cells for allogeneic transplantation: a review. Stem Cells. 2001;19(2):108-17. doi: 10.1634/stemcells.19-2-108.
- Background: PubMed 10627699Nehrer S, Spector M, Minas T. Histologic analysis of tissue after failed cartilage repair procedures. Clin Orthop Relat Res. 1999 Aug;(365):149-62. doi: 10.1097/00003086-199908000-00020.
- Background: PubMed 16140804Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20. doi: 10.2106/JBJS.D.02846.
- Background: PubMed 30237933Minas T, Ogura T, Bryant T. Autologous Chondrocyte Implantation. JBJS Essent Surg Tech. 2016 Jun 22;6(2):e24. doi: 10.2106/JBJS.ST.16.00018. eCollection 2016 Jun 22.
- Background: PubMed 20720135Fortier LA, Potter HG, Rickey EJ, Schnabel LV, Foo LF, Chong LR, Stokol T, Cheetham J, Nixon AJ. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. J Bone Joint Surg Am. 2010 Aug 18;92(10):1927-37. doi: 10.2106/JBJS.I.01284.
- Background: PubMed 17656639Lee KB, Hui JH, Song IC, Ardany L, Lee EH. Injectable mesenchymal stem cell therapy for large cartilage defects--a porcine model. Stem Cells. 2007 Nov;25(11):2964-71. doi: 10.1634/stemcells.2006-0311. Epub 2007 Jul 26.
- Background: PubMed 21862278McIlwraith CW, Frisbie DD, Rodkey WG, Kisiday JD, Werpy NM, Kawcak CE, Steadman JR. Evaluation of intra-articular mesenchymal stem cells to augment healing of microfractured chondral defects. Arthroscopy. 2011 Nov;27(11):1552-61. doi: 10.1016/j.arthro.2011.06.002. Epub 2011 Aug 20.
- Background: PubMed 20392971Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Anz, MD principal investigator
Orthopedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessi Truett (8509168570, jessica.truett@andrewsref.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beckman-Coulter Flow Cytometer (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573412, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.