Adult Double Unit Cord Blood TransplantNCT06712108
Double Unit Cord Blood Transplant in Hematologic Malignancies.
An observational study of Adult Double Unit Cord Blood Transplant, run by Seoul National University Hospital at 6 sites in South Korea.
Trial summary
The efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Double Unit Cord Blood Transplant
- What is being tested?
- tranplant
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 21 Dec 2023to 31 Mar 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with malignant hematologic diseases who are eligible for allogeneic hematopoietic stem cell transplantation
Who may be able to join
- Aged 19 and older
- Patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases:
- Acute leukemia (myeloid/lymphoid/mixed lineage) / Myelodysplastic syndromes / Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms / Malignant lymphomas, multiple myeloma / Other malignant hematologic malignancies / bone marrow failure diseases, including aplastic anemia
- If all contents of the consent form are understood and consented to in writing.
Who cannot join
- Patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation).
- Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.
- Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.
- Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Not yet recruiting
Keimyung Unversity Dongsan Hospital
Daegu
Young Rok Do
Young Rok Do
- Not yet recruiting
Jeonbuk National University Hopital
Jeonju, Jeonlabuk-do
Ho Young Yhim
Jae Yong Kwak
- Not yet recruiting
Dong-A University Hospital
Pusan
Sung Hyun Kim
Sung Hyun Kim
- Not yet recruiting
Pusan National University Hospital
Pusan
Do Young Kim
Ho Jin Shin
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam
Soo Mee Bang
Soo Mee Bang
- Recruiting
Seoul National University Hospital
Seoul
Dong-Yeop Shin, MD, PhD
Eunhee Park, RN
About this study
Official title: PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients With Hematologic Diseases.
The efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection
- Conditions
- Adult Double Unit Cord Blood Transplant
- Being tested
- tranplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranplantProcedure or surgery
double unit cord blood transplnat
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with hematologic disease who will receive double unit cord blood tranplant | Not described Receives: Procedure: tranplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 2 years
Secondary outcomes (5)
engraftment
Frequency of engraftment
Measured: 30 days
GVHD
acute and chronic GVHD
Measured: 2 years
PFS
Progression-free survival
Measured: 2 years
TRM
Treatment related mortality
Measured: 3 months
Relapse
Relapse rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start21 Dec 2023
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Double Unit Cord Blood TransplantStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Yeop Shin, Seoul National University Hospital
- Investigators
- Dong-Yeop Shin, MD, PhD., Principal investigator, Seoul National University HospitalSung-Soo Yoon, MD, PhD., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712108
- Sponsor's protocol ID
- PRODUCT-K
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients With Hematologic Diseases.
- ClinicalTrials.gov ID
- NCT06712108
- Acronym / sponsor ID
- PRODUCT-K
- Conditions
- Adult Double Unit Cord Blood Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 2 Dec 2024 (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 efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with hematologic disease who will receive double unit cord blood tranplant | – | Procedure: tranplant |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with malignant hematologic diseases who are eligible for allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (4 listed)
- Aged 19 and older
- Patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases:
- Acute leukemia (myeloid/lymphoid/mixed lineage) / Myelodysplastic syndromes / Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms / Malignant lymphomas, multiple myeloma / Other malignant hematologic malignancies / bone marrow failure diseases, including aplastic anemia
- If all contents of the consent form are understood and consented to in writing.
Key exclusion criteria (4 listed)
- Patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation).
- Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.
- Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.
- Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.
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 |
|---|---|---|
| tranplantdouble unit cord blood transplnat | Procedure or surgery | Adult patients with hematologic disease who will receive double unit cord blood tranplant |
Primary outcome
Overall Survival
Time frame: 2 years
5 secondary outcomes
engraftment
Time frame: 30 days
GVHD
Time frame: 2 years
PFS
Time frame: 2 years
TRM
Time frame: 3 months
Relapse
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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.
Dong-Yeop Shin, MD, PhD. principal investigator
Seoul National University Hospital
Sung-Soo Yoon, MD, PhD. study director
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Double Unit Cord Blood Transplant, run by Seoul National University Hospital at 6 sites in South Korea.
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 4 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Yeop Shin, MD, PhD. (+82-2-2072-7209, shindongyeop@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.