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

NCT ID: NCT01841632

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

MultiStem

Intervention Type: DRUG

Interventions

MultiStem

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Regensburg

OTHER

Sponsor Role: collaborator

Healios K.K.

INDUSTRY

Sponsor Role: collaborator

Prof. Dr. Marc-H. Dahlke, Ph. D.

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marc-H. Dahlke, Ph. D.

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Surgery, University Hospital Regensburg

Regensburg, Bavaria, Germany

Countries

Germany

References

Popp FC, Fillenberg B, Eggenhofer E, Renner P, Dillmann J, Benseler V, Schnitzbauer AA, Hutchinson J, Deans R, Ladenheim D, Graveen CA, Zeman F, Koller M, Hoogduijn MJ, Geissler EK, Schlitt HJ, Dahlke MH. Safety and feasibility of third-party multipotent adult progenitor cells for immunomodulation therapy after liver transplantation--a phase I study (MISOT-I). J Transl Med. 2011 Jul 28;9:124. doi: 10.1186/1479-5876-9-124.

Reference Type: BACKGROUND

PMID: 21798013 (View on PubMed)

Dillmann J, Popp FC, Fillenberg B, Zeman F, Eggenhofer E, Farkas S, Scherer MN, Koller M, Geissler EK, Deans R, Ladenheim D, Loss M, Schlitt HJ, Dahlke MH. Treatment-emergent adverse events after infusion of adherent stem cells: the MiSOT-I score for solid organ transplantation. Trials. 2012 Nov 15;13:211. doi: 10.1186/1745-6215-13-211.

Reference Type: BACKGROUND

PMID: 23151227 (View on PubMed)

Other Identifiers

2009-017795-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MISOT-I

Identifier Type: -

Identifier Source: org_study_id