Platelet CryopreservationPLT-CRIONCT07235436
Platelet Cryopreservation
An observational study of Platelet Cryopreservation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The study "Cryopreservation of Platelets for Prophylactic Use in Onco-Hematology: an in vitro Study", coordinated by Dr. Lucia Merolle at the Department of Transfusion Medicine of the Azienda USL-IRCCS of Reggio Emilia, aims to investigate the impact of cryopreservation methods on platelet functionality and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Platelet Cryopreservation
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 31 Dec 2020to 30 Apr 2025
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Platelet donors
Who may be able to join
- Written informed consent
Who cannot join
- refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryopreservation of Platelets for Prophylactic Use in Onco-haematology: an in Vitro Study
The study "Cryopreservation of Platelets for Prophylactic Use in Onco-Hematology: an in vitro Study", coordinated by Dr. Lucia Merolle at the Department of Transfusion Medicine of the Azienda USL-IRCCS of Reggio Emilia, aims to investigate the impact of cryopreservation methods on platelet functionality and metabolism. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The study design involves the recruitment of donors, preparation of platelet concentrates, and their cryopreservation. After thawing, the products undergo a series of biochemical and functional evaluations, including platelet count, pH measurement, pro-inflammatory cytokine levels, morphological assessment, and activity testing. Data will then be analyzed to determine the minimal effective concentration required for safe and effective use. Platelet apheresis samples are collected and analyzed. Participation is proposed to platelet donors at the Department of Transfusion Medicine, and inclusion requires the signing of written informed consent, while refusal to provide consent will exclude individuals from the study.
Read the detailed description
Platelets are essential blood components with pivotal roles in both hemostasis and inflammation. Thrombocytopenia, defined as a reduction in circulating platelet count, may result from impaired bone marrow production, increased consumption, splenic sequestration, or bleeding episodes, and is commonly managed through platelet transfusions aimed at restoring adequate counts and, when necessary, controlling hemorrhage. In clinical practice, the majority of platelet transfusions are administered to thrombocytopenic cancer patients with a prophylactic intent, where the primary requirement is sustained platelet survival to minimize the number of transfusions. Conversely, in actively bleeding patients, platelet transfusions are expected to provide rapid and efficient hemostasis, while their circulation time is of lesser relevance. Currently, platelet concentrates are stored at room temperature (22-24 °C) under continuous agitation for up to five days, after which they are discarded if unused. This storage method carries the risk of bacterial contamination and induces metabolic and structural changes that compromise platelet function, a phenomenon known as platelet storage lesion (PSL). Furthermore, the short shelf life limits the availability of platelets in emergency settings, as observed during the SARS-CoV-2 pandemic, when the demand for prophylactic platelet transfusions remained constant while supply was severely strained. In response, the Transfusion Medicine Unit in Reggio Emilia introduced cryopreservation of platelet concentrates to prevent future shortages. Cryopreservation allows storage of platelets for up to two years, offering an attractive alternative to conventional methods, not only extending storage duration but also reducing the risl of bacterial contamination. Although recent studies have demonstrated the safety and efficacy of cryopreserved platelets in bleeding patients, limited evidence exists for their use in prophylaxis among onco-hematologic patients. Major concerns include the potential for exacerbating thrombotic risk in patients with chronic hypercoagulability and the release of bioactive molecules such as growth factors and pro-inflammatory cytokines during thawing, which could have pro-tumorigenic effects. Platelet-tumor interactions are known to be complex, exerting both pro- and anti-tumoral influences, with the balance often favoring tumor progression. The present study therefore aims to evaluate the impact of cryopreservation on platelet functionality, structure and morphology, as well as to assess potential pro-tumoral effects after thawing. Using a comparative approach, cryopreserved platelets obtained by apheresis were analyzed alongside standard room-temperature stored platelets, currently considered the gold standard for prophylactic transfusion. The protocol involves donor recruitment at the Transfusion Medicine Unit of the AUSL-IRCCS of Reggio Emilia, with platelet concentrates prepared and cryopreserved using 6% dimethyl sulfoxide (DMSO) as well as alternative approaches employing intracellular and extracellular cryoprotectants, either individually or in combination, with lower cytotoxicity reported in other transfusion and cryobiology settings. Platelet samples were evaluated before freezing and after thawing at multiple time points (1, 3, and 6 hours post-reconstitution). Analyses included recovery rate, pH changes, release of bioactive factors, activation markers, hemostatic potential (via thromboelastography), and morphological alterations assessed by flow cytometry, microscopy, and synchrotron-based Fourier transform infrared (FTIR) microspectroscopy. Furthermore, the potential pro-tumoral activity of cryopreserved versus fresh platelets was investigated in vitro using co-culture systems with breast cancer and leukemia cell lines, focusing on proliferation, and platelet-cell interaction tests. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The secondary objective is to identify the cryopreserved platelet product with the most appropriate safety profile for prophylactic transfusion in onco-hematologic patients. The study is conducted by the BioMetLab at the Transfusion Medicine Unit of AUSL-IRCCS of Reggio Emilia in compliance with the Declaration of Helsinki, following informed consent from all donors.
- Conditions
- Platelet Cryopreservation
- Keywords
- onco-hematological patient, cryopreservation, transfusion, platelets
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Recovery Rate After Cryopreservation (Percentage of Initial Count)
Platelet recovery will be assessed by calculating the percentage of platelets remaining after cryopreservation compared to pre-freezing values, expressed as recovery rate (%).
Measured: through study completion, an average of 4 year
Absolute Platelet Count After Cryopreservation (×10⁹/L)
Platelet concentration will be determined using an automated hematology analyzer, expressed as absolute platelet count in ×10⁹/L.
Measured: through study completion, an average of 4 year
Platelet Function Assessed by Thromboelastography - Clot Formation Time
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include clot formation time (in minutes) as a measure of platelet functional activity.
Measured: through study completion, an average of 4 year
Platelet Function Assessed by Thromboelastography - Maximum Amplitude
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include maximum amplitude (in millimeters) as a measure of platelet functional activity.
Measured: through study completion, an average of 4 years
Secondary outcomes (5)
Release of Pro-Inflammatory Cytokines After Cryopreservation (Concentration in pg/mL)
Levels of IL-6 and TNF-α will be quantified in platelet supernatants using ELISA assays, expressed in pg/mL.
Measured: through study completion, an average of 4 year
Morphological Integrity of Platelets After Cryopreservation (Percentage of Normal Platelets)
Morphology will be assessed by light microscopy and flow cytometry, expressed as the percentage of platelets retaining normal morphology.
Measured: through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Clotting Time
Hemostatic potential will be evaluated with thromboelastography (TEG). The outcome includes clotting time (in minutes) as a measure of the hemostatic process.
Measured: through study completion, an average of 4 year
Pro-Tumoral Activity of Cryopreserved Platelets in Co-Culture with Cancer Cell Lines (Percentage Increase in Cell Proliferation)
Platelet-tumor interaction will be assessed in vitro using breast cancer and leukemia cell lines. Results will be expressed as the percentage increase in cancer cell proliferation compared to controls.
Measured: through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Maximum Clot Firmness
Hemostatic potential will be evaluated with thromboelastography (TEG). The outcome includes maximum clot firmness (in millimeters) as a measure of clot stability.
Measured: through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start31 Dec 2020
- Primary completion12 Apr 2021
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Platelet CryopreservationStudies 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235436
- Sponsor's protocol ID
- 1221/2020/TESS/IRCCSRE
- Acronym
- PLT-CRIO
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
Publications
Ang AL, Gan LSH, Tuy TT, Ang CH, Tan CW, Tan HH, Shu PH, Zhang Q, Cao Y, Moorakonda RB, Pokharkar Y, Lu J. A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients. Transfusion. 2023 Sep;63(9):1649-1660. doi: 10.1111/trf.17503. Epub 2023 Aug 19.
PubMed 37596937Christodoulides A, Zeng Z, Alves NJ. In-vitro thromboelastographic characterization of reconstituted whole blood utilizing cryopreserved platelets. Blood Coagul Fibrinolysis. 2021 Dec 1;32(8):556-563. doi: 10.1097/MBC.0000000000001075.
PubMed 34475333Jimenez-Marco T, Castrillo A, Hierro-Riu F, Vicente V, Rivera J. Frozen and cold-stored platelets: reconsidered platelet products. Platelets. 2022 Jan 2;33(1):27-34. doi: 10.1080/09537104.2021.1967917. Epub 2021 Aug 22.
PubMed 34423718Reade MC, Marks DC, Howe B, McGuinness S, Parke R, Navarra L, Charlewood R, Johnson L, McQuilten Z; CLIP-II and CLIPNZ-II Investigators.; CLIP-II and CLIPNZ-II Investigators. Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials). BMJ Open. 2022 Dec 20;12(12):e068933. doi: 10.1136/bmjopen-2022-068933.
PubMed 36600425Johnson L, Tan S, Wood B, Davis A, Marks DC. Refrigeration and cryopreservation of platelets differentially affect platelet metabolism and function: a comparison with conventional platelet storage conditions. Transfusion. 2016 Jul;56(7):1807-18. doi: 10.1111/trf.13630. Epub 2016 May 9.
PubMed 27158813Johnson L, Reade MC, Hyland RA, Tan S, Marks DC. In vitro comparison of cryopreserved and liquid platelets: potential clinical implications. Transfusion. 2015 Apr;55(4):838-47. doi: 10.1111/trf.12915. Epub 2014 Nov 5.
PubMed 25371169Johnson L, Tan S, Jenkins E, Wood B, Marks DC. Characterization of biologic response modifiers in the supernatant of conventional, refrigerated, and cryopreserved platelets. Transfusion. 2018 Apr;58(4):927-937. doi: 10.1111/trf.14475. Epub 2018 Jan 12.
PubMed 29330877Slichter SJ, Jones M, Ransom J, Gettinger I, Jones MK, Christoffel T, Pellham E, Bailey SL, Corson J, Bolgiano D. Review of in vivo studies of dimethyl sulfoxide cryopreserved platelets. Transfus Med Rev. 2014 Oct;28(4):212-25. doi: 10.1016/j.tmrv.2014.09.001. Epub 2014 Sep 21.
PubMed 25439164Gavioli G, Razzoli A, Bedolla DE, Di Bartolomeo E, Quartieri E, Iotti B, Berni P, Birarda G, Vaccari L, Schiroli D, Marraccini C, Baricchi R, Merolle L. Cryopreservation affects platelet macromolecular composition over time after thawing and differently impacts on cancer cells behavior in vitro. Platelets. 2023 Dec;34(1):2281943. doi: 10.1080/09537104.2023.2281943. Epub 2023 Nov 27.
PubMed 38010129
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreservation of Platelets for Prophylactic Use in Onco-haematology: an in Vitro Study
- ClinicalTrials.gov ID
- NCT07235436
- Acronym / sponsor ID
- PLT-CRIO / 1221/2020/TESS/IRCCSRE
- Conditions
- Platelet Cryopreservation
- Keywords
- onco-hematological patient, cryopreservation, transfusion, platelets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Nov 2025 (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 study "Cryopreservation of Platelets for Prophylactic Use in Onco-Hematology: an in vitro Study", coordinated by Dr. Lucia Merolle at the Department of Transfusion Medicine of the Azienda USL-IRCCS of Reggio Emilia, aims to investigate the impact of cryopreservation methods on platelet functionality and metabolism. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The study design involves the recruitment of donors, preparation of platelet concentrates, and their cryopreservation. After thawing, the products undergo a series of biochemical and functional evaluations, including platelet count, pH measurement, pro-inflammatory cytokine levels, morphological assessment, and activity testing. Data will then be analyzed to determine the minimal effective concentration required for safe and effective use. Platelet apheresis samples are collected and analyzed. Participation is proposed to platelet donors at the Department of Transfusion Medicine, and inclusion requires the signing of written informed consent, while refusal to provide consent will exclude individuals from the study.
Detailed description
Platelets are essential blood components with pivotal roles in both hemostasis and inflammation. Thrombocytopenia, defined as a reduction in circulating platelet count, may result from impaired bone marrow production, increased consumption, splenic sequestration, or bleeding episodes, and is commonly managed through platelet transfusions aimed at restoring adequate counts and, when necessary, controlling hemorrhage. In clinical practice, the majority of platelet transfusions are administered to thrombocytopenic cancer patients with a prophylactic intent, where the primary requirement is sustained platelet survival to minimize the number of transfusions. Conversely, in actively bleeding patients, platelet transfusions are expected to provide rapid and efficient hemostasis, while their circulation time is of lesser relevance. Currently, platelet concentrates are stored at room temperature (22-24 °C) under continuous agitation for up to five days, after which they are discarded if unused. This storage method carries the risk of bacterial contamination and induces metabolic and structural changes that compromise platelet function, a phenomenon known as platelet storage lesion (PSL). Furthermore, the short shelf life limits the availability of platelets in emergency settings, as observed during the SARS-CoV-2 pandemic, when the demand for prophylactic platelet transfusions remained constant while supply was severely strained. In response, the Transfusion Medicine Unit in Reggio Emilia introduced cryopreservation of platelet concentrates to prevent future shortages. Cryopreservation allows storage of platelets for up to two years, offering an attractive alternative to conventional methods, not only extending storage duration but also reducing the risl of bacterial contamination. Although recent studies have demonstrated the safety and efficacy of cryopreserved platelets in bleeding patients, limited evidence exists for their use in prophylaxis among onco-hematologic patients. Major concerns include the potential for exacerbating thrombotic risk in patients with chronic hypercoagulability and the release of bioactive molecules such as growth factors and pro-inflammatory cytokines during thawing, which could have pro-tumorigenic effects. Platelet-tumor interactions are known to be complex, exerting both pro- and anti-tumoral influences, with the balance often favoring tumor progression. The present study therefore aims to evaluate the impact of cryopreservation on platelet functionality, structure and morphology, as well as to assess potential pro-tumoral effects after thawing. Using a comparative approach, cryopreserved platelets obtained by apheresis were analyzed alongside standard room-temperature stored platelets, currently considered the gold standard for prophylactic transfusion. The protocol involves donor recruitment at the Transfusion Medicine Unit of the AUSL-IRCCS of Reggio Emilia, with platelet concentrates prepared and cryopreserved using 6% dimethyl sulfoxide (DMSO) as well as alternative approaches employing intracellular and extracellular cryoprotectants, either individually or in combination, with lower cytotoxicity reported in other transfusion and cryobiology settings. Platelet samples were evaluated before freezing and after thawing at multiple time points (1, 3, and 6 hours post-reconstitution). Analyses included recovery rate, pH changes, release of bioactive factors, activation markers, hemostatic potential (via thromboelastography), and morphological alterations assessed by flow cytometry, microscopy, and synchrotron-based Fourier transform infrared (FTIR) microspectroscopy. Furthermore, the potential pro-tumoral activity of cryopreserved versus fresh platelets was investigated in vitro using co-culture systems with breast cancer and leukemia cell lines, focusing on proliferation, and platelet-cell interaction tests. The primary objective of this project is to determine the effects of cryogenic storage on platelet function. The secondary objective is to identify the cryopreserved platelet product with the most appropriate safety profile for prophylactic transfusion in onco-hematologic patients. The study is conducted by the BioMetLab at the Transfusion Medicine Unit of AUSL-IRCCS of Reggio Emilia in compliance with the Declaration of Helsinki, following informed consent from all donors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Platelet donors
Key inclusion criteria (1 listed)
- Written informed consent
Key exclusion criteria (1 listed)
- refusal or inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet Recovery Rate After Cryopreservation (Percentage of Initial Count)
Time frame: through study completion, an average of 4 year
Platelet recovery will be assessed by calculating the percentage of platelets remaining after cryopreservation compared to pre-freezing values, expressed as recovery rate (%).
Absolute Platelet Count After Cryopreservation (×10⁹/L)
Time frame: through study completion, an average of 4 year
Platelet concentration will be determined using an automated hematology analyzer, expressed as absolute platelet count in ×10⁹/L.
Platelet Function Assessed by Thromboelastography - Clot Formation Time
Time frame: through study completion, an average of 4 year
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include clot formation time (in minutes) as a measure of platelet functional activity.
Platelet Function Assessed by Thromboelastography - Maximum Amplitude
Time frame: through study completion, an average of 4 years
Hemostatic function will be analyzed using thromboelastography (TEG). The outcome will include maximum amplitude (in millimeters) as a measure of platelet functional activity.
5 secondary outcomes
Release of Pro-Inflammatory Cytokines After Cryopreservation (Concentration in pg/mL)
Time frame: through study completion, an average of 4 year
Morphological Integrity of Platelets After Cryopreservation (Percentage of Normal Platelets)
Time frame: through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Clotting Time
Time frame: through study completion, an average of 4 year
Pro-Tumoral Activity of Cryopreserved Platelets in Co-Culture with Cancer Cell Lines (Percentage Increase in Cell Proliferation)
Time frame: through study completion, an average of 4 year
Hemostatic Potential by Thromboelastography - Maximum Clot Firmness
Time frame: through study completion, an average of 4 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 37596937Ang AL, Gan LSH, Tuy TT, Ang CH, Tan CW, Tan HH, Shu PH, Zhang Q, Cao Y, Moorakonda RB, Pokharkar Y, Lu J. A randomized cross-over study of cryopreserved platelets in prophylactic transfusions of thrombocytopenic patients. Transfusion. 2023 Sep;63(9):1649-1660. doi: 10.1111/trf.17503. Epub 2023 Aug 19.
- Background: PubMed 34475333Christodoulides A, Zeng Z, Alves NJ. In-vitro thromboelastographic characterization of reconstituted whole blood utilizing cryopreserved platelets. Blood Coagul Fibrinolysis. 2021 Dec 1;32(8):556-563. doi: 10.1097/MBC.0000000000001075.
- Background: PubMed 34423718Jimenez-Marco T, Castrillo A, Hierro-Riu F, Vicente V, Rivera J. Frozen and cold-stored platelets: reconsidered platelet products. Platelets. 2022 Jan 2;33(1):27-34. doi: 10.1080/09537104.2021.1967917. Epub 2021 Aug 22.
- Background: PubMed 36600425Reade MC, Marks DC, Howe B, McGuinness S, Parke R, Navarra L, Charlewood R, Johnson L, McQuilten Z; CLIP-II and CLIPNZ-II Investigators.; CLIP-II and CLIPNZ-II Investigators. Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials). BMJ Open. 2022 Dec 20;12(12):e068933. doi: 10.1136/bmjopen-2022-068933.
- Background: PubMed 27158813Johnson L, Tan S, Wood B, Davis A, Marks DC. Refrigeration and cryopreservation of platelets differentially affect platelet metabolism and function: a comparison with conventional platelet storage conditions. Transfusion. 2016 Jul;56(7):1807-18. doi: 10.1111/trf.13630. Epub 2016 May 9.
- Background: PubMed 25371169Johnson L, Reade MC, Hyland RA, Tan S, Marks DC. In vitro comparison of cryopreserved and liquid platelets: potential clinical implications. Transfusion. 2015 Apr;55(4):838-47. doi: 10.1111/trf.12915. Epub 2014 Nov 5.
- Background: PubMed 29330877Johnson L, Tan S, Jenkins E, Wood B, Marks DC. Characterization of biologic response modifiers in the supernatant of conventional, refrigerated, and cryopreserved platelets. Transfusion. 2018 Apr;58(4):927-937. doi: 10.1111/trf.14475. Epub 2018 Jan 12.
- Background: PubMed 25439164Slichter SJ, Jones M, Ransom J, Gettinger I, Jones MK, Christoffel T, Pellham E, Bailey SL, Corson J, Bolgiano D. Review of in vivo studies of dimethyl sulfoxide cryopreserved platelets. Transfus Med Rev. 2014 Oct;28(4):212-25. doi: 10.1016/j.tmrv.2014.09.001. Epub 2014 Sep 21.
- Results publication: PubMed 38010129Gavioli G, Razzoli A, Bedolla DE, Di Bartolomeo E, Quartieri E, Iotti B, Berni P, Birarda G, Vaccari L, Schiroli D, Marraccini C, Baricchi R, Merolle L. Cryopreservation affects platelet macromolecular composition over time after thawing and differently impacts on cancer cells behavior in vitro. Platelets. 2023 Dec;34(1):2281943. doi: 10.1080/09537104.2023.2281943. Epub 2023 Nov 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Platelet Cryopreservation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Recovery Rate After Cryopreservation (Percentage of Initial Count) (time frame: through study completion, an average of 4 year). The study lists 4 primary outcomes in all. 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 NCT07235436, which also lists 9 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 19 Nov 2025.