Study to Evaluate Hepatic Artery Injection of Autologous Human Bone Marrow-Derived MSCs in Patients With Alcoholic LC
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|ClinicalTrials.gov Identifier: NCT03838250|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcoholic Liver Cirrhosis||Biological: Cellgram™ (Bone marrow-derived MSCs)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single-dose injection of autologous bone marrow-derived mesenchymal stem cells (Cellgram™) will be administered to the patient by an experienced interventional radiologist.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Single-Dose Study to Evaluate the Safety and Efficacy of Hepatic Artery Injection of Autologous Human Bone Marrow-Derived Mesenchymal Stem Cells (Cellgram™) in Patients With Alcoholic Liver Cirrhosis|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||June 2021|
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.
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 [ Time Frame: 12 months ]
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.
- Number of patients with Hepatocellular carcinoma (primary liver cancer) development [ Time Frame: 12 months ]assessed via ultrasonography and alpha fetoprotein [AFP] analysis
- Incidence of Adverse Events [ Time Frame: 12 months ]Incidence of Adverse Events as assessed by vital signs, physical examination, safety laboratory tests, and patient reporting
- Liver stiffness measurement [ Time Frame: 12 months ]with transient elastography (i.e., FibroScan®)
- How well the Liver is functioning [ Time Frame: 12 months ]
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
- Chronic liver disease as assessed by the Child-Pugh score [ Time Frame: 12 months ]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.
- Model for End-Stage Liver Disease (MELD) Score [ Time Frame: 12 months ]
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
- Overall survival [ Time Frame: 12 months ]defined as the time from infusion until death from any cause during the study period.
- Quality of life as assessed by 36-Item Short Form Survey (SF-36) Questionnaire [ Time Frame: 12 months ]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.
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): NCT03838250
|Contact: JIYEOUN JEONG, firstname.lastname@example.org|
|Principal Investigator:||Juan Gallegos-Orozco, Ph.D||University of Utah|