NCT01875081

Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient.

Completed Phase 2 Last updated 16 March 2016

What this trial tests

Phase 2 trial testing Livercellgram in Alcoholic Liver Cirrhosis in 72 participants. Completed in 1 March 2016.

Timeline

1 November 2012

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Pharmicell Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	1 November 2012
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across South Korea

Drugs / interventions tested

• Livercellgram — full drug profile →

Conditions studied

• Alcoholic Liver Cirrhosis — all drugs for Alcoholic Liver Cirrhosis →

Sponsor

Pharmicell Co., Ltd. — full company profile →

Who can join

Adults 20 to 70, any sex, with Alcoholic Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)
  Time frame: 6 month after cell therapy

Sponsor's own description

If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.

A participant that satisfies all selection and exclusion criteria is assigned randomly to a test group (1-time or 2-time injection group) or control group (no-cell therapy group). Participants assigned to the 1-time injection group conduct cell therapy within 1 month after bone marrow aspiration. Before implementing cell therapy, implement hepatic artery catheterization which inserts a catheter into the hepatic artery through the right aorta femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells. Participants assigned to the 2-time injection group store 1-time injection amount of mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will re-inject autologous mesenchymal stem cells within 1 month after first injection.

Participants will make a total of 8 hospital visits on a 4-week interval after registration, and effectiveness and safety will be evaluated based on a fixed procedure on every visit.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical application of mesenchymal stem cell in regenerative medicine: a narrative review.
   Margiana R, Margiana R, Margiana R, Markov A, et al · · 2022 · cited 263× · PMID 35902958 · DOI 10.1186/s13287-022-03054-0
2. Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
   Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
3. A Brief Overview of Global Trends in MSC-Based Cell Therapy.
   Jovic D, Yu Y, Wang D, Wang K, et al · · 2022 · cited 186× · PMID 35344199 · DOI 10.1007/s12015-022-10369-1
4. Clinical trials using mesenchymal stem cells in liver diseases and inflammatory bowel diseases.
   Tsuchiya A, Kojima Y, Ikarashi S, Seino S, et al · · 2017 · cited 60× · PMID 29259715 · DOI 10.1186/s41232-017-0045-6
5. Mesenchymal stem cell therapy for liver fibrosis/cirrhosis.
   Cao Y, Ji C, Lu L. · · 2020 · cited 59× · PMID 32775363 · DOI 10.21037/atm.2020.02.119
6. Current Perspectives Regarding Stem Cell-Based Therapy for Liver Cirrhosis.
   Kwak KA, Cho HJ, Yang JY, Park YS. · · 2018 · cited 46× · PMID 29670867 · DOI 10.1155/2018/4197857
7. Mesenchymal stromal cells: promising treatment for liver cirrhosis.
   Yao L, Hu X, Dai K, Yuan M, et al · · 2022 · cited 42× · PMID 35841079 · DOI 10.1186/s13287-022-03001-z
8. Cell-based liver therapies: past, present and future.
   Iansante V, Chandrashekran A, Dhawan A. · · 2018 · cited 32× · PMID 29786563 · DOI 10.1098/rstb.2017.0229