NCT02218437

Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells（Umbilical Cord Derived）

Child With Severe Aplastic Anemia (SAA) Therapy: the Injection of Umbilical Cord Derived Mesenchymal Stem Cells.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Accepted

Summary

Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and takes part in the bone marrow microenvironment. The response rate of early treatment on Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG treatment) is associated with long-term effect. The injection of Umbilical Cord Derived Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.

Detailed description

1. Mesenchymal Stem Cells were prepared by in vitro separation, screening, and culture from healthy human umbilical cord tissue; The " injection of mesenchymal stem cells (umbilical) manufacturing and verification regulation " was also formulated. 2. The starting dose of Umbilical Cord Derived MSC was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; And the maximum tolerated dose was 1 \* 107 cells /kg 3. The response and complete remission rate, relapse rate of the injection of Umbilical Cord Derived Mesenchymal Stem Cells (or combined with ATG ) for Child with SAA were determined.

Conditions

• Complications of Organ Transplant Stem Cells Umbilical Cord

Interventions

Type	Name	Description
DRUG	MSC+ATG	MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-08-18
• Last updated: 2014-08-18

Locations

1 site across 1 country: China