CompletedPhase 4

Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis

India5 participantsStarted 2019-07-01

Plain-language summary

Though the results of autologous CD34+ cell infusion and MSC in independent studies have shown promise, yet they are yet to reach the desired long term outcome. The possible postulation for this is possibly because when using autologous CD34+ cell infusion, the inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized CD 34+ cells. MSC have immunomodulatory effect (ref) and may improve the liver environment making it more beneficial for the CD34+ cells to function and survive. In addition, MSC has ben shown to produce hepatocyte growth factor which is protective against liver injury and beneficial for liver regeneration (shown in above tables). However, it remains to be understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand the residual hepatocyte population. MSC can also directly inhibit the activation of hepatic stellate cells, the main source of extracellular matrix via MSC derived IL 10 and TNF-αand may also induce hepatic stellate cell apoptosis. Current lacunae in cell based therapy is based on the poor consensus and understanding on the best type of cells to be used, the ideal number of cells, the most appropriate route of administration and the need for repeat dosing . The concept that combination of autologous hematopoietic and mesenchymal stem cells infusion may be more beneficial than infusing any one of them alone has been discussed in many scientific forums but there are no study till date to either see the safety as well as the efficacy of this proof of concept . With this above background data, we propose a study design which will be a safety study for combination use of autologous CD34+ and MSC

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 20-70 years * Clinically diagnosed for hepatic cirrhosis having a Child Pugh score of B or MELD \>10 but below 20 * Not willing for immediate liver transplantation either due to lack of donor tissue or financial issues * Platelet count of \> 80,000 and INR \<1.6 * Life expectancy of at least 3 months based on MELD score and Child Pugh Score * Ability to give informed consent Exclusion Criteria: * Age less than 20 or more than 70 years * Have liver tumors or history of any other cancer * Pregnant or lactating women * Patients with hepato-renal syndrome and acute kidney injury (Any creatinine \> 1.6 will be excluded) * Evidence of ongoing sepsis - as per Surviving sepsis guideline * Recent gastrointestinal bleeding or spontaneous bacterial peritonitis (within last one month) * Any HIV positive patients * Co-morbid conditions such as severe cardiac and/or pulmonary disease * Inability to give informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the safety of combination of hematopoetic and mesenchymal stem cell in patients of liver cirrhosis.

Timeframe: Up to 6 months

Trial details

NCT IDNCT04243681

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-01

View on ClinicalTrials.gov More Cirrhosis, Liver trials