Evidence map›Paper›PMID 35068788›Full record

ArticleJournal of clinical and experimental hepatology

Safety Assessment of Autologous Stem Cell Combination Therapy in Patients With Decompensated Liver Cirrhosis: A Pilot Study.

Mithun Sharma, Pavan K Pondugala, Shashidhar Jaggaihgari, Sasikala Mitnala, Vemula V Krishna, Ganesh Jaishetwar, Pragati Naik, Pramod Kumar, Anand Kulkarni, Rajesh Gupta and 8 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Journal of clinical and experimental hepatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04243681 (Combination of Autologous Mesenchymal and Hematopoietic Stem Cell Infusion in Patients With Decompensated Cirrhosis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04243681 phase4completednot on this map

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

TypeinterventionalSponsorAsian Institute of Gastroenterology, IndiaRan2019 to 2020Enrolled5ConditionsCirrhosis, LiverArmsCD 34 and MSC infusion, Standard of care for Cirrhosis management
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. [Clinical progress in stem cell therapy for end-stage liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Review
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 2 institutions in 1 country.

Mithun SharmaAsian Institute of Gastroenterology, Hyderabad, India.
Pavan K PondugalaAsian Healthcare Foundation, Hyderabad, India.
Shashidhar JaggaihgariAsian Healthcare Foundation, Hyderabad, India.
Sasikala MitnalaAsian Healthcare Foundation, Hyderabad, India.
Vemula V KrishnaAsian Healthcare Foundation, Hyderabad, India.
Ganesh JaishetwarYashoda Hospital, Hyderabad, India.
Pragati NaikAsian Institute of Gastroenterology, Hyderabad, India.
Pramod KumarAsian Institute of Gastroenterology, Hyderabad, India.
Anand KulkarniAsian Institute of Gastroenterology, Hyderabad, India.
Rajesh GuptaAsian Institute of Gastroenterology, Hyderabad, India.
Jagdeesh R SinghAsian Institute of Gastroenterology, Hyderabad, India.
Santosh DarisettyAsian Institute of Gastroenterology, Hyderabad, India.
Anuradha SekharanAsian Institute of Gastroenterology, Hyderabad, India.
Duvurr N ReddyAsian Institute of Gastroenterology, Hyderabad, India.
Guduru V RaoAsian Institute of Gastroenterology, Hyderabad, India.
Fatima SyedaAsian Institute of Gastroenterology, Hyderabad, India.
Nitin JagtapAsian Institute of Gastroenterology, Hyderabad, India.
Padaki N RaoAsian Institute of Gastroenterology, Hyderabad, India.
Asian Institute of Gastroenterology · INYashoda Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHaematopoietic stem cell (HSC) infusion has demonstrated short-term improvement in liver functions in patients with chronic liver disease. The combination of HSC with mesenchymal stem cells (MSCs), which has an immunomodulatory effect, may augment the effects and enhance the duration of improvements on liver functions. The aim of the present study was to assess the safety of infusing the combination of autologous HSCs and MSCs in decompensated liver cirrhosis.

methodsIn phase I of the study, in vitro assessment was performed to observe the effect of coculturing MSCs with HSCs on their viability and cytokine profiles. Phase II of the study was to assess the safety of combination of stem cell infusions. Bone marrow (50 ml) was aspirated for MSC isolation and expansion using standard protocol. Patients received subcutaneous doses (n = 5) of granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization followed by leukapheresis for harvesting HSCs using CliniMacs. HSCs and MSCs were infused through the hepatic artery under fluoroscopic guidance and were monitored for any adverse effects.

resultsIn vitro studies revealed 94% viable HSCs in coculture similar to monoculture. HSCs released only interleukin (IL)-8, whereas MSCs secreted IL-8 and IL-6 in monocultures, and both IL-8 and IL-6 were secreted in coculture. G-CSF administration- and bone marrow aspiration-related complications were not observed. Infusion of the cells through the hepatic artery was safe, and no postprocedural complications were noted.

conclusionThe combination of autologous HSC and MSC infusion is a safe procedure in patients with decompensated liver cirrhosis, and the outcomes needed to be assessed in larger studies. TRIAL NUMBER: NCT04243681.

Indexed as

7-AAD, 7-aminoactinomycin DAFP, alpha-fetoproteincath-lab, cardiac catheterization laboratoryCBA, cytokine cytometric bead assaycirrhosis of liverCLD, chronic liver diseasecombination of stem cellsDMEM-KO, Dulbecco's modified Eagle's Knock out mediumFBS, foetal bovine serumG-CSF, granulocyte colony-stimulating factorHSC, haematopoietic stem cellIL, interleukinMELD, Model for End-Stage Liver Diseasemesenchymal stem cellsMNC, mononuclear cellMSC, mesenchymal stem cellSOP, standard operating procedurestem cellsTJLB, transjugular liver biopsyUSG, ultrasonography

Identifiers

PMID35068788
PMCPMC8766547
OpenAlexW3149688723

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.