MultiStem ® is a new biological product, manufactured from human stem cells obtained from adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune system function and augment tissue repair. Standard of care pharmacological immunosuppression after liver transplantation can achieve reasonable survival of liver grafts and patients. The side effects of this treatment, however, are clinically significant and diminish the overall success of organ transplantation as a curative therapy. It is therefore the objective of this study to implement cellular immunomodulation therapy with MultiStem as an adjunct to standard pharmacological immunosuppression with the ultimate goal of significantly reducing drug-based immunosuppression. As this is the first study with MultiStem in this subject population it has been designed as a safety and feasibility trial. However, first evidence of a potential benefit for this patient population will be explored cautiously.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Department of Surgery, University Hospital Regensburg
Regensburg, Bavaria, Germany
Infusional and Acute Toxicity, Using Toxicity Scoring Mechanism
* For the description of intraportal toxicity a doppler ultrasound examination will be performed to assess various parameters that describe velocity of flow and flow pattern. * For pulmonary toxicity the assessment begins with an arterial blood gas. If this reveals pathological findings, a chest X-ray is required for clinical reasons independent of the study enrolment. In addition, clinical data describing the need for postoperative re-intubation will be recorded and the patient is assessed for the occurrence of a pulmonary embolism according to clinical guidelines. * For systemic toxicity, the occurrence of anaphylactic shock due to standard clinical guidelines is recorded.
Time frame: up to day 30 (+10)
Time to First Biopsy-proven Acute Rejection
Per protocol biopsies will be performed on days 1, 4, 10. Additional biopsies will be taken whenever clinically necessary.
Time frame: up to day 90 (+/-30)
Evidence Confirming That MultiStem Does Not Promote Malignant Transformation or Tumor Growth
Four additional outpatient visits are planned to further evaluate the study patients (including screening for malignancies).
Time frame: up to day 365 (+/-30)
Evaluation of Data From Routine Examinations Following Last Study Visit for Evidence of Long Term Safety From MultiStem Administration
The results of routine examinations, which are necessary for all transplant patients, will be used once a year and analyzed retrospectively.
Time frame: up to six years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.