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A Phase I Study of Mesenchymal Stromal Cells for the Treatment of Acute and Chronic Graft versus Host Disease

Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase I
12 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Protocol IDs
EPIC2014-MSC002 (primary)
Study Sponsor
Emory University/Winship Cancer Institute


This phase I trial studies the side effects and best dose of mesenchymal stem cells in treating patients with graft-versus-host disease that happens within the first 6 months after transplant (acute) or at least 3 months after transplant (chronic). Stem cell transplant involves taking stem cells from a donor and giving them to a patient to replace cells damaged by cancer. Sometimes the newly transplanted cells recognize patient’s cells as foreign and attack them, causing graft-versus-host disease. Giving patients with graft-versus-host disease a type of their own stem cells, called mesenchymal stem cells, that have been multiplied in a laboratory may help prevent the donor’s cells from attacking the patient’s cells and may be effective in treating graft-versus-host disease.



I. To determine the safety and tolerability of infusing escalating doses of autologous mesenchymal stromal cells (MSCs) (mesenchymal stem cells) for patients with acute or chronic graft-versus-host disease (GVHD).


I. To assess the overall response rate of acute and chronic GVHD to autologous MSC infusion.

II. To determine the effect of MSC infusion on lymphocyte phenotype, inflammatory biomarkers and GVHD specific biomarker levels.

OUTLINE: This is a dose-escalation study.

Patients receive autologous mesenchymal stromal cells intravenously (IV) over 10-20 minutes on day 1; days 1 and 8; or days 1, 8, 15, and 22.

After completion of study treatment, patients are followed up at days 36 and 42, at months 2-6 and 9, and at 1 year.

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