Recruiting
Phase 1

MSCs

Sponsor:

Pharmicell Co., Ltd.

Code:

NCT03838250

Conditions

Alcoholic Liver Cirrhosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Cellgram™ (Bone marrow-derived MSCs)

Study Details

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

Study ID

NCT03838250

Start date

Jun 20, 2019

Status verified date

Oct, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Alcoholic liver cirrhosis as diagnosed by clinical, biochemical, radiological, or histological evidence.
2. Male or female, 18 to 70 years of age, inclusive.
3. Child-Pugh class B (7 to 9 points)
4. Capable, in the Investigators opinion, of undergoing hepatic artery catheterization.
5. 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.
6. Provision of informed consent by the patient (or their legal representative) to participate in the clinical study.
7. Able, in the Investigator's opinion, to comply with the requirements of the protocol (including the follow-up period).
8. 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.

Exclusion Criteria:

1. Current diagnosis of malignant hematologic disease (e.g., acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma).
2. Etiology other than alcohol for underlying liver cirrhosis.
3. Baseline creatinine >1.7 mg/dL and/or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
4. 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.
5. Model for End-Stage Liver Disease score >20.
6. International normalized ratio >3.0 and/or platelet counts <30,000/mm3
7. Major operation within 3 months prior to screening.
8. Presence of extrahepatic biliary stricture.
9. Participant has undergone transjugular intrahepatic portosystemic shunt.
10. Active hepatic artery or portal vein thrombosis.
11. Presence of advanced hepatic encephalopathy Stages 3-4 (West Haven criteria) at the time of screening.
12. Active variceal bleeding during the last 6 months before screening.
13. Severe cardiac, renal, or respiratory failure.
14. Positive serological test results for human immunodeficiency virus (HIV), HCV, hepatitis B surface antigen (HBsAg) and/or syphilis.
15. Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the EOS visit.
16. Positive urine pregnancy test at Screening.
17. Drug abuse within the past 2 years (as confirmed by patient disclosure or a urine drug screen conducted at Screening).
18. Participation in an interventional clinical study within 30 days prior to screening.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cellgram™ (Bone marrow-derived MSCs)

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.

Interventions

Cellgram™ (Bone marrow-derived MSCs)

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).

Primary outcome measure

  • Incidence of Serious Adverse Events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

JIYEOUN JEONG, CCRP, Bachelor

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

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Juan Gallegos-Orozco, Ph.D

801-581-7878juan.gallegos@hsc.utah.edu

More Information

Sponsor

Pharmicell Co., Ltd.

Last update posted

Oct 22, 2020

Last verified

Oct, 2020

Keywords

  • Alcoholic
  • Liver
  • Cirrhosis
  • Liver Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pharmicell Co., Ltd. on 2020-10-22.