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Cirrhosis, LiverPhase 4NCT04243681

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

A Phase 4 study testing CD 34 and MSC infusion in people with Cirrhosis, Liver, run by Asian Institute of Gastroenterology, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Cirrhosis, Liver
What is being tested?
CD 34 and MSC infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteIndia
Study dates
1 Jul 2019to 1 Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Any HIV positive patients
  • Co-morbid conditions such as severe cardiac and/or pulmonary disease
  • Inability to give informed consent

Trial locations and contacts

1 site in 1 country.

India1 site

  • Asian Institute Of Gastroenterology

    Hyderabad, Telangana, 500032

Other trials in India

About this study

Official title: Combination of Autologous Mesenchymal and Hematopoietic Stem Cell Infusion in Patients With Decompensated Cirrhosis: A Pilot Study

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

Being tested
CD 34 and MSC infusion, Standard of care for Cirrhosis management
Keywords
Mesenchymal Stem Cell, Hematopoetic Stem cell, Autologous transfusion
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD 34 and MSC infusionCombination product

    Also called Stem cell infusion

    Combination of stem cells

  • Standard of care for Cirrhosis managementDrug

    Drugs used for Cirrhosis management such as Diuretics, Hepatoprotective agents and Lactulose

Study groups in NCT04243681
Study groupRoleWhat they receive
Combination MSC and HSCExperimentalPatient will receive a combination of mesenchymal and Hematopoetic stem cell through hepatic artery under fluroscopic guidance
Receives: Combination Product: CD 34 and MSC infusion
Standard of care for Cirrhosis managementActive comparatorDiuretics, Hepatoprotective agents and Lactulose
Receives: Drug: Standard of care for Cirrhosis management

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Any adverse events after the use of combination stem cell treatment would be recorded:

    • Bone marrow aspiration related complications such as pain (>6 on VAS) and bleeding from the site.
    • Leukapheresis related complications such as hypotension and hypocalcemia.
    • Hepatic artery catheterization related complications such as pain or discomfort at the catheter insertion site, bleeding and infection.
    • Post MSC and CD34 infusion related adverse reactions would be recorded using CDSCO form.

    Measured: Up to 6 months

Secondary outcomes (3)

  1. Change in MELD (Model for End stage Liver disease) score.

    Difference in MELD score from baseline to follow-up period.

    Measured: Up to 6 months

  2. Change in Child Pugh score.

    Difference in Child Pugh score from baseline to follow-up period.

    Measured: Up to 6 months

  3. Change in the percentage of CD 34 cells in liver.

    To assess improvement in the percentage of CD 34 cells in liver by performing a paired liver biopsy- before and after infusion.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start1 Jul 2019
  3. Primary completion1 Aug 2020
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243681
Sponsor's protocol ID
ECR/346/Inst/AP/2013
Status last verified
Jan 2020
First submitted
14 Aug 2019
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amer ME, El-Sayed SZ, El-Kheir WA, Gabr H, Gomaa AA, El-Noomani N, Hegazy M. Clinical and laboratory evaluation of patients with end-stage liver cell failure injected with bone marrow-derived hepatocyte-like cells. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):936-41. doi: 10.1097/MEG.0b013e3283488b00.

    PubMed 21900788

  • Hang HL, Xia Q. Role of BMSCs in liver regeneration and metastasis after hepatectomy. World J Gastroenterol. 2014 Jan 7;20(1):126-32. doi: 10.3748/wjg.v20.i1.126.

    PubMed 24415865

  • Gordon MY, Levicar N, Pai M, Bachellier P, Dimarakis I, Al-Allaf F, M'Hamdi H, Thalji T, Welsh JP, Marley SB, Davies J, Dazzi F, Marelli-Berg F, Tait P, Playford R, Jiao L, Jensen S, Nicholls JP, Ayav A, Nohandani M, Farzaneh F, Gaken J, Dodge R, Alison M, Apperley JF, Lechler R, Habib NA. Characterization and clinical application of human CD34+ stem/progenitor cell populations mobilized into the blood by granulocyte colony-stimulating factor. Stem Cells. 2006 Jul;24(7):1822-30. doi: 10.1634/stemcells.2005-0629. Epub 2006 Mar 23.

    PubMed 16556705

  • Sharma M, Pondugala PK, Jaggaihgari S, Mitnala S, Krishna VV, Jaishetwar G, Naik P, Kumar P, Kulkarni A, Gupta R, Singh JR, Darisetty S, Sekharan A, Reddy DN, Rao GV, Syeda F, Jagtap N, Rao PN. Safety Assessment of Autologous Stem Cell Combination Therapy in Patients With Decompensated Liver Cirrhosis: A Pilot Study. J Clin Exp Hepatol. 2022 Jan-Feb;12(1):80-88. doi: 10.1016/j.jceh.2021.03.010. Epub 2021 Apr 2.

    PubMed 35068788

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CD 34 and MSC infusion in people with Cirrhosis, Liver, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety of combination of hematopoetic and mesenchymal stem cell in patients of liver cirrhosis. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243681, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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