Study to Evaluate Hepatic Artery Injection of Autologous Human Bone Marrow-Derived MSCs in Patients With Alcoholic LC

NCT03838250 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: PMC-P-08
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.

Conditions

Alcoholic Liver Cirrhosis

Keywords

Alcoholic; Liver; Cirrhosis; Liver Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events

  An SAE suggests a significant hazard, contraindication, side-effect, or precaution. With respect to human clinical experience, this includes any event that: * Results in death. * Is life-threatening.\* * Requires in-patient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect. * Other medically important condition * Life-threatening in the definition of a SAE or adverse reaction refers to an event in which the patient was at risk of death at the time of event; it does not refer to an event, which hypothetically might have caused death if it were more severe.

  12 months

Secondary Outcomes (8)

• Number of patients with Hepatocellular carcinoma (primary liver cancer) development

  12 months

• Incidence of Adverse Events

  12 months

• Liver stiffness measurement

  12 months

• How well the Liver is functioning

  12 months

• Chronic liver disease as assessed by the Child-Pugh score

  12 months

Study Arms (1)

Cellgram™ (Bone marrow-derived MSCs)

EXPERIMENTAL

Infusion Cellgram™(Bone marrow-derived MSCs). Single dose administration of approximately 5 x 10\^7 cells/10 mL (range: 4.5 x 10\^7 to 5.5 x 10\^7 cells/10 mL) via the hepatic artery.

Biological: Cellgram™ (Bone marrow-derived MSCs)

Interventions

Cellgram™ (Bone marrow-derived MSCs) BIOLOGICAL

Approximately 15 to 30 mL of bone marrow is aspirated from the posterior iliac crest of patients under local anesthesia. Approximately 30 days (±7 days) after BM aspiration, the participant will return to the study center for admission and for the infusion Cellgram™ (Bone marrow-derived MSCs).

Cellgram™ (Bone marrow-derived MSCs)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcoholic liver cirrhosis as diagnosed by clinical, biochemical, radiological, or histological evidence.
• Male or female, 18 to 70 years of age, inclusive.
• Child-Pugh class B (7 to 9 points)
• Capable, in the Investigators opinion, of undergoing hepatic artery catheterization.
• No consumption of alcohol or other potentially hepatotoxic substances considered clinically relevant in the opinion of the Investigator, within 6 months prior to screening and throughout the study.
• Provision of informed consent by the patient (or their legal representative) to participate in the clinical study.
• Able, in the Investigator's opinion, to comply with the requirements of the protocol (including the follow-up period).
• Females of childbearing potential must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study. Highly effective methods of birth control include hormonal birth control, intrauterine devices (IUDs), or any double-barrier method (sponges, female condoms) used by the woman in addition to contraception used by their male partner such as vasectomy or condom supplemented with spermicide.

You may not qualify if:

• Current diagnosis of malignant hematologic disease (e.g., acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma).
• Etiology other than alcohol for underlying liver cirrhosis.
• Baseline creatinine \>1.7 mg/dL and/or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
• Clinical history of a solid cancer within 5 years prior to screening or current diagnosis of a solid cancer (including hepatocellular carcinoma assessed by ultrasonography and elevated AFP level) and currently receiving cancer treatment.
• Continuous use of a clinically relevant amount of steroids or antibiotics within 1 month prior to screening. Clinical relevance will be determined by the Investigator.
• Model for End-Stage Liver Disease score \>20.
• International normalized ratio \>3.0 and/or platelet counts \<30,000/mm3
• Major operation within 3 months prior to screening.
• Presence of extrahepatic biliary stricture.
• Participant has undergone transjugular intrahepatic portosystemic shunt.
• Active hepatic artery or portal vein thrombosis.
• Presence of advanced hepatic encephalopathy Stages 3-4 (West Haven criteria) at the time of screening.
• Active variceal bleeding during the last 6 months before screening.
• Severe cardiac, renal, or respiratory failure.
• Positive serological test results for human immunodeficiency virus (HIV), HCV, hepatitis B surface antigen (HBsAg) and/or syphilis.

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Fibrosis; Liver Diseases

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Digestive System Diseases; Liver Diseases, Alcoholic; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Juan Gallegos-Orozco, Ph.D

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIYEOUN JEONG, CCRP, Bachelor

CONTACT

82-02-3496-0134; jyjeong@pharmicell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-dose injection of autologous bone marrow-derived mesenchymal stem cells (Cellgram™) will be administered to the patient by an experienced interventional radiologist.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: February 12, 2019
• Study Start: June 20, 2019
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)