Acute LeukemiaPhase 1/2NCT00823316
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
A Phase 1/2 study testing Human umbilical cord blood-derived mesenchymal stem cells in people with Acute Leukemia, run by Medipost Co Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic… Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Human umbilical cord blood-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Feb 2010
- Phase
- Phase 1/2
- 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age 2~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia
- Patient never has an experience of hematopoietic stem cell transplantation
- Patient must have an acute leukemia with a complete remission.
- Patients must have an ECOG 0~2.
- No moderate or sever organ dysfunction : Ejection fraction > 45%; Creatinine <2.0 mg/ml; Serum bilirubin < 2 mg/ml; AST/ALT < 200 IU/L.
- Patient must not have an transplantation with different source of hematopoietic stem cell such as bone marrow and cord blood.
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- Patient must not have an infection needed an administration of non-oral antibiotics.
- No active severe infection derived form virus or fungus.
- Each patient / patient's guardian must sign written informed consent.
Who cannot join
- Patient has previously received hematopoietic stem cell transplantation.
- Patient plans to have a related hematopoietic stem cell transplantation.
- Patient has a severe internal disease.
- Patient has enrolled another clinical trial study within last 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
Read the detailed description
- Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells capable of reconstituting normal bone marrow function are administered to a patient. This procedure has been used to treat adults and children with life-threatening hematological malignancies and congenital immunodeficiency disorders.
- In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating capacity to achieve engraftments resulting in continued generation of functional blood elements from the engrafted living cells. Transplantation of unrelated hematopoietic stem cells originating either from adult bone marrow or from peripheral blood often leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure after transplantation.
- In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote engraftment and to reduce the immunological reactions giving rise to GvHD.
- There is a growing interest in co-transplantation of MSC and HSC to improve the donor outcome in the unrelated HSCT condition.
- Conditions
- Acute Leukemia
- Being tested
- Human umbilical cord blood-derived mesenchymal stem cells
- Keywords
- Mesenchymal Stem Cells, Allogeneic Transplantation, Engraftment, GvHD, Childhood, unrelated HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord blood-derived mesenchymal stem cellsBiological
Also called PROMOSTEM
1x1,000,000 hMSC/kg, IV after unrelated HSCT
Human umbilical cord blood-derived mesenchymal stem cellsBiological
Also called PROMOSTEM
5x1,000,000 hMSC/kg, IV after unrelated HSCT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | at a dose of 1x1,000,000 hMSC/kg Receives: Biological: Human umbilical cord blood-derived mesenchymal stem cells |
| 2 | Experimental | at a dose of 5x1,000,000 hMSC/kg Receives: Biological: Human umbilical cord blood-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
Measured: 28 and 100 days
Secondary outcomes (1)
- AGVHD grade
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Hoe Koo, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823316
- Sponsor's protocol ID
- MP-CR-MSC003
- Status last verified
- Apr 2012
- First submitted
- 13 Jan 2009
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT00823316
- Acronym / sponsor ID
- MP-CR-MSC003
- Conditions
- Acute Leukemia
- Keywords
- Mesenchymal Stem Cells, Allogeneic Transplantation, Engraftment, GvHD, Childhood, unrelated HSCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Jan 2009 (estimated)
- 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 purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
Detailed description
- Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells capable of reconstituting normal bone marrow function are administered to a patient. This procedure has been used to treat adults and children with life-threatening hematological malignancies and congenital immunodeficiency disorders.
- In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating capacity to achieve engraftments resulting in continued generation of functional blood elements from the engrafted living cells. Transplantation of unrelated hematopoietic stem cells originating either from adult bone marrow or from peripheral blood often leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure after transplantation.
- In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote engraftment and to reduce the immunological reactions giving rise to GvHD.
- There is a growing interest in co-transplantation of MSC and HSC to improve the donor outcome in the unrelated HSCT condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Human umbilical cord blood-derived mesenchymal stem cellsat a dose of 1x1,000,000 hMSC/kg |
| 2 | Experimental | Biological: Human umbilical cord blood-derived mesenchymal stem cellsat a dose of 5x1,000,000 hMSC/kg |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patient age 2~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia
- Patient never has an experience of hematopoietic stem cell transplantation
- Patient must have an acute leukemia with a complete remission.
- Patients must have an ECOG 0~2.
- No moderate or sever organ dysfunction : Ejection fraction > 45%; Creatinine <2.0 mg/ml; Serum bilirubin < 2 mg/ml; AST/ALT < 200 IU/L.
Key exclusion criteria (4 listed)
- Patient has previously received hematopoietic stem cell transplantation.
- Patient plans to have a related hematopoietic stem cell transplantation.
- Patient has a severe internal disease.
- Patient has enrolled another clinical trial study within last 4 weeks.
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 |
|---|---|---|
| Human umbilical cord blood-derived mesenchymal stem cellsAlso: PROMOSTEM1x1,000,000 hMSC/kg, IV after unrelated HSCT | Biological | 1 |
| Human umbilical cord blood-derived mesenchymal stem cellsAlso: PROMOSTEM5x1,000,000 hMSC/kg, IV after unrelated HSCT | Biological | 2 |
Primary outcome
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
Time frame: 28 and 100 days
1 secondary outcome
- AGVHD grade
Time frame: 100 days
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 23 Apr 2012.
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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.
Hong Hoe Koo, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human umbilical cord blood-derived mesenchymal stem cells in people with Acute Leukemia, run by Medipost Co Ltd. at 1 site 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 9 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: finished, as of the sponsor's last update on 23 Apr 2012. 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate (time frame: 28 and 100 days). 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 23 Apr 2012.