NCT03529136

Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis

Status unknown Phase 2 Last updated 18 May 2018

What this trial tests

Phase 2 trial testing UC-MSC in Decompensated Liver Cirrhosis in 252 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
31 December 2019

30 April 2020

Quick facts

Lead sponsor	Shandong Qilu Stem Cells Engineering Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	252
Start date	1 June 2018
Primary completion	31 December 2019
Estimated completion	30 April 2020

Drugs / interventions tested

• UC-MSC — full drug profile →

Conditions studied

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

Sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Decompensated Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients. However, the severe shortage of donor livers, high cost, and potential serious complications have restricted the availability of liver transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be safe and effective for liver diseases in some pre-clinical and clinical studies. This study aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of MSC transfusion.

Publications & conference data

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

1. The Potential Use of Mesenchymal Stem Cells and Their Derived Exosomes for Orthopedic Diseases Treatment.
   Malekpour K, Hazrati A, Zahar M, Markov A, et al · · 2022 · cited 73× · PMID 34169411 · DOI 10.1007/s12015-021-10185-z
2. Human Wharton's Jelly-Cellular Specificity, Stemness Potency, Animal Models, and Current Application in Human Clinical Trials.
   Stefańska K, Ożegowska K, Hutchings G, Popis M, et al · · 2020 · cited 52× · PMID 32290584 · DOI 10.3390/jcm9041102
3. Applications of Mesenchymal Stem Cells in Liver Fibrosis: Novel Strategies, Mechanisms, and Clinical Practice.
   Zhu M, Hua T, Ouyang T, Qian H, et al · · 2021 · cited 24× · PMID 34434239 · DOI 10.1155/2021/6546780
4. Locoregional delivery of stem cell-based therapies.
   Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564
5. Mesenchymal stem cell therapy as a game-changer in liver diseases: review of current clinical trials.
   Huang WC, Li YC, Chen PX, Ma KS, et al · · 2025 · cited 14× · PMID 39762946 · DOI 10.1186/s13287-024-04127-y
6. Advance of Mesenchymal Stem Cells in Chronic End-Stage Liver Disease Control.
   Gao Y, Yin X, Ren X. · · 2022 · cited 9× · PMID 36248254 · DOI 10.1155/2022/1526217
7. Cell therapy for end-stage liver disease: Current state and clinical challenge.
   Zhang L, Deng Y, Bai X, Wei X, et al · · 2024 · cited 5× · PMID 39602326 · DOI 10.1097/cm9.0000000000003332
8. From signaling pathways to clinical trials: mesenchymal stem cells as multimodal regenerative architects in liver cirrhosis therapy.
   Bozorgi V, Babaahmadi M, Salehi M, Vafaeimanesh J, et al · · 2025 · cited 4× · PMID 40764597 · DOI 10.1186/s13287-025-04535-8