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Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01841632
Recruitment Status : Terminated
First Posted : April 26, 2013
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
University Hospital Regensburg
Athersys, Inc
Information provided by (Responsible Party):
Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: MultiStem Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Multipotent Adult Progenitor Cells for Immunomodulation Therapy After Liver Transplantation: A Phase I Study of the MiSOT Study Consortium
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MultiStem

Dose escalation

Cohort 1

Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 2

Drug: MultiStem, Dose 2 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 3

Drug: MultiStem, Dose 3 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 4

Drug: MultiStem, Dose 4 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

 Drug: MultiStem


Outcome Measures
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Primary Outcome Measures :
  1. Infusional and Acute Toxicity, Using Toxicity Scoring Mechanism [ Time Frame: up to day 30 (+10) ]
    • 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.


Secondary Outcome Measures :
  1. Time to First Biopsy-proven Acute Rejection [ Time Frame: up to day 90 (+/-30) ]
    Per protocol biopsies will be performed on days 1, 4, 10. Additional biopsies will be taken whenever clinically necessary.

  2. Evidence Confirming That MultiStem Does Not Promote Malignant Transformation or Tumor Growth [ Time Frame: up to day 365 (+/-30) ]
    Four additional outpatient visits are planned to further evaluate the study patients (including screening for malignancies).

  3. Evaluation of Data From Routine Examinations Following Last Study Visit for Evidence of Long Term Safety From MultiStem Administration [ Time Frame: up to six years ]
    The results of routine examinations, which are necessary for all transplant patients, will be used once a year and analyzed retrospectively.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age undergoing allogeneic liver transplantation
  • Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Written informed consent prior to any study procedures

Exclusion Criteria:

  • Known allergies to bovine or porcine products or any other ingredients of the product
  • Patients older than 65 years of age
  • Patients listed in a high-urgency status that would not allow proper preparation of the study interventions
  • Patients receiving a secondary liver graft (Re-Transplantation)
  • Double organ transplant recipients
  • Pre-existing renal failure that requires or has required hemodialysis within the last year
  • Pulmonary function: FEV1, FVC, DLCO ≤50% predicted
  • Cardiac function: left ventricular ejection fraction ≤50%
  • HIV seropositive, varicella virus active infection or any other clinically relevant infection
  • History of any malignancy (including lymphoproliferative disease and hepatocellular carcinoma) except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence
  • Unstable myocardium (evolving myocardial infarction), cardiogenic shock
  • Females of childbearing potential (hormonal status and gynecological consultation required)
  • Patients with portal vein thrombosis
  • Patients with a history of pulmonary embolism
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841632


Locations
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Germany
Department of Surgery, University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Prof. Dr. Marc-H. Dahlke, Ph. D.
University Hospital Regensburg
Athersys, Inc
More Information
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Publications:

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Responsible Party: Prof. Dr. Marc-H. Dahlke, Ph. D., Sponsor-Investigator, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT01841632    
Other Study ID Numbers: MISOT-I
2009-017795-25 ( EudraCT Number )
First Posted: April 26, 2013    Key Record Dates
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018
Last Verified: December 2017
Keywords provided by Prof. Dr. Marc-H. Dahlke, Ph. D., University Hospital Regensburg:
Liver transplantation
Allogeneic liver transplantation
Solid organ transplantation