Pilot Study of Donor Virus-Specific T-Cells to Treat Cytomegalovirus (CMV) or Adenovirus (AdV) Infections After Solid Organ or Stem Cell Transplant
Phase: Recruiting
First Posted: October
Condition(s): Cytomegalovirus (CMV), Adenovirus (AdV)
NCT Number: NCT03665675 Other Study ID Number(s): OSU CMV CTL
What Is the Purpose of This Study?
The purpose of this study is to assess how safe and practical a new treatment (anti-viral cytotoxic T-lymphocytes, or CTLs) is for patients who have had a solid organ transplant (SOT) or hematopoietic cell transplant (HCT) and are dealing with an infection or reactivation of cytomegalovirus (CMV) or adenovirus (AdV). The study will also examine any side effects, both positive and negative, linked to the treatment.
Who Can Take Part in This Study?
- Infants < 6 months of age
- Documented HSV infection confirmed by PCR test or culture from:
- Blood
- Surface areas (skin or mucous membranes)
- Cerebrospinal fluid (fluid around the brain and spinal cord)
- Evidence of widespread infection, meaning the virus has spread to at least 2 different, separate areas of the body
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT03665675
What Will Happen During This Study?
- Before starting therapy, patients will have many tests done. This will include blood draws, EKGs, X-rays, and other procedures.
- While patients are receiving active therapy they will be followed closely.
- Depending on how well they tolerate the therapy, they may have blood tests or other procedures.
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