A Phase 1 interventional study of Cellgram™ (Bone marrow-derived MSCs) in Alcoholic Liver Cirrhosis, sponsored by Pharmicell Co., Ltd.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Pharmicell Co., Ltd. · Phase 1, Interventional, and Treatment
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.
After providing written informed consent, subjects will return to the study center for further evaluation and to have their Bone marrow harvested by an experienced hematologist or interventional radiologist.
Within approximately 1 month (30 ± 7 days) after Bone marrow aspiration, study participants will be admitted to the study center on Day 1.
At the study center, the participant will undergo hepatic artery catheterization by an interventional radiologist who will inject a single dose of Cellgram™. Participants will remain as in-patients and be observed for 24 hours post-infusion. Following discharge, participants will periodically return to the study center for study assessment visits over a period of 1 year.
When a suitable candidate is identified by the Investigator, the Investigator or designated healthcare professional will ask the patient about his/her willingness to be included in the clinical study. Following this, patients will be allowed sufficient time, in their own opinion, to consider study entry, and will be offered the opportunity to ask any further questions prior to signing the informed consent form.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Pharmicell Co., Ltd. is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
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)
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).
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.
Time frame: 12 months
Number of patients with Hepatocellular carcinoma (primary liver cancer) development
assessed via ultrasonography and alpha fetoprotein \[AFP\] analysis
Time frame: 12 months
Incidence of Adverse Events
Incidence of Adverse Events as assessed by vital signs, physical examination, safety laboratory tests, and patient reporting
Time frame: 12 months
Liver stiffness measurement
with transient elastography (i.e., FibroScan®)
Time frame: 12 months
How well the Liver is functioning
by tests including: serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, albumin, gamma glutamyl transpeptidase (GGT) and creatinine. Units of Measure: AST will be report in U/L. ALT will be report in U/L. GGT will be report in U/L. Bilirubin will be report in mg/dL. creatinine will be report in mg/dL. Albumin will be report in g/dL
Time frame: 12 months
Chronic liver disease as assessed by the Child-Pugh score
The Child-Pugh Score will be used to determine the prognosis, required strength of treatment and the necessity of liver transplantation. The score employs 5 clinical measures of liver disease (total bilirubin, serum albumin, INR, ascites and hepatic encephalopathy). Each parameter is scored 1 to 3, with 3 indicating the most severe derangement.
Time frame: 12 months
Model for End-Stage Liver Disease (MELD) Score
MELD uses the patient's values for serum bilirubin, serum creatinine, and the INR for PT to predict survival. It is calculated according to the following formula defined by Kamath et al (2001): MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43
Time frame: 12 months
Overall survival
defined as the time from infusion until death from any cause during the study period.
Time frame: 12 months
Quality of life as assessed by 36-Item Short Form Survey (SF-36) Questionnaire
The Short Form-36 Quality Of Life questionnaire will be recorded for each patient. The 8 subscales of the SF-36 (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health) and 2 summary component measures (Physical Component Summary, Mental Component Summary) will be calculated and summarized.
Time frame: 12 months
Plan to share: Undecided
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Pharmicell Co., Ltd.