NCT00136903

Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)

A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC) transplant.

Detailed description

Protocol 260 - Participants will be randomized with equal probability to the treatment arms (2 million cells/kilogram (kg) of Prochymal® or 8 million cells/kg of Prochymal®) using a stratified block design. The stratification factor is acute GVHD grade. For the purpose of stratification, the GVHD grades are II and III-IV. Treatment with investigational agent will be administered on study Days 1 and 4. Participants will be followed for safety and efficacy until Day 28 after initiation of treatment with the investigational agent, or until withdrawal or death, whichever occurs first. Protocol 261- This study is designed as a long-term safety follow-up of participants who take part in the preceding clinical study of Prochymal® (Protocol 260) for the treatment of acute GVHD. Participants will be enrolled in Study 261 upon completion of the preceding Study 260.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	Prochymal® - 2 Million cells/kg	2 million hMSCs/kg actual body weight, IV on study Days 1 and 4
DRUG	Prochymal®- 8 Million cells/kg	8 million hMSCs/kg actual body weight IV on study Days 1 and 4
DRUG	Methylprednisolone	Methylprednisolone 2 mg/kg administered intravenously.
DRUG	Prednisone	Prednisone 2.5 mg/kg administered orally.
DRUG	Cyclosporine	Administered as prescribed by the caregiver.
DRUG	Tacrolimus	Administered as prescribed by the caregiver.
DRUG	Mycophenolate Mofetil	Administered as prescribed by the caregiver.

Timeline

• Start date: 2005-04-27
• Primary completion: 2006-07-28
• Completion: 2008-07-14
• First posted: 2005-08-29
• Last updated: 2022-01-31

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study