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Graft vs Host Disease (GVHD) - Healing Genes
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Graft vs Host Disease (GVHD)

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BMT Autologous MSCs for GvHD

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


Phase 1

DESCRIPTION:

Doctors at the Children’s Healthcare of Atlanta/Emory University are recruiting patients who have received an allogeneic (donor) stem cell transplant leukemia, lymphoma or other cancer of the blood and developed Graft vs Host Disease (GVHD). These patients may be eligible to trial an autologous (to the self) stem cell transplant developed from the patient’s own mesenchymal stromal cells (MSCs). MSCs have the ability to differentiate into immune cells, potentially reducing or eliminating GVHD.

The treatment recovers the MSCs from the patient’s bone marrow, multiplies them in the lap for 14 days, and then administers them back to the patient at 1 of 3 dose levels in a single infusion. Follow up occurs at 6 months and up to 5 total years will be tracked.


PATIENT MUST:

  • Be 12 years of age and older
  • Have received an allogeneic stem cell transplant for a hematologic malignancy
  • Have acute or chronic GVHD meeting the study’s criteria for its status and past treatment
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate.
  2. Surgery to recover bone marrow MSCs (an outpatient procedure).
  3. 14 days will elapse while the MSCs are amplified and prepared for transplant.
  4. Patients will receive a single infusion of the MSCs.
  5. Follow up occurs at 6 months and up to 5 total years will be tracked.

LOCATIONS AND CONTACTS:

Trials will take place at the Children’s Healthcare of Atlanta/Emory University in Atlanta, GA, Map.

Contacts:

Ashley Griffin  |  404-785-0653  |  [email protected]

Chanta Whitlow  |  4047850696  |  [email protected]

 

 

 

SPONSOR INFORMATION:

Emory University

CURE Foundation

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02359929

 

 

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