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

NCT00823316 | Completed Phase 1 DMC

• 1 other identifier: MP-CR-MSC003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 stem cell transplantation for children with acute leukemia.

Conditions

Acute Leukemia

Keywords

Mesenchymal Stem Cells; Allogeneic Transplantation; Engraftment; GvHD; Childhood; unrelated HSCT

Outcome Measures

Primary Outcomes (1)

• - Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate

  28 and 100 days

Secondary Outcomes (1)

• - AGVHD grade

  100 days

Study Arms (2)

1

EXPERIMENTAL

at a dose of 1x1,000,000 hMSC/kg

Biological: Human umbilical cord blood-derived mesenchymal stem cells

2

EXPERIMENTAL

at a dose of 5x1,000,000 hMSC/kg

Biological: Human umbilical cord blood-derived mesenchymal stem cells

Interventions

Human umbilical cord blood-derived mesenchymal stem cells BIOLOGICAL

1x1,000,000 hMSC/kg, IV after unrelated HSCT

Also known as: PROMOSTEM

1

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipost Co Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

• Hong Hoe Koo, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

KR (1)