Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation - Full Text View

Sponsored by:	Medipost Co Ltd.
Information provided by:	Medipost Co Ltd.
ClinicalTrials.gov Identifier:	NCT00823316

Purpose

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.

Condition	Intervention	Phase
Acute Leukemia	Biological: Human umbilical cord blood-derived mesenchymal stem cells	Phase I Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy 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.

Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:

- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate [ Time Frame: 28 and 100 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- AGVHD grade [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental at a dose of 1x1,000,000 hMSC/kg	Biological: Human umbilical cord blood-derived mesenchymal stem cells 1x1,000,000 hMSC/kg, IV after unrelated HSCT
2: Experimental at a dose of 5x1,000,000 hMSC/kg	Biological: Human umbilical cord blood-derived mesenchymal stem cells 5x1,000,000 hMSC/kg, IV after unrelated HSCT

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.

Eligibility

Ages Eligible for Study:	2 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823316

Contacts

Contact: Wonil Oh, MD, PhD	+82-2-3465-6677	wioh@medi-post.co.kr
Contact: Young Jin Heo, MS	+82-2-866-7141	hyj@medi-post.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Keon Hee Yoo, MD +82-2-3532-3410 hema2170@skku.edu

Sponsors and Collaborators

Medipost Co Ltd.

Investigators

Principal Investigator:

Hong Hoe Koo, MD, PhD

Samsung Medical Center

More Information

No publications provided

Responsible Party:	MEDIPOST Co., Ltd. ( Wonil Oh / Vice President )
Study ID Numbers:	MP-CR-MSC003
Study First Received:	January 13, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00823316 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:

Mesenchymal Stem Cells
Allogeneic Transplantation
Engraftment

GvHD
Childhood
unrelated HSCT

Study placed in the following topic categories:

Graft Versus Host Disease
Leukemia
Graft vs Host Disease
Homologous Wasting Disease

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Graft vs Host Disease

ClinicalTrials.gov processed this record on May 07, 2009