Evidence map›Paper›PMID 35873716›Full record

ArticleAmerican journal of stem cells2022

Phase 1 clinical trial for intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with moderate COVID-19 virus pneumonia: results of stage 1 of the study.

Alok Sharma, Rohit Kulkarni, Hemangi Sane, Nilkanth Awad, Abhijit Bopardikar, Anagha Joshi, Sujata Baweja, Mohan Joshi, Chandra Vishwanathan, Nandini Gokulchandran and 5 more

Open access · greenAbstract read
In one paragraph

Article in American journal of stem cells, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. 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

15 authors at 2 institutions in 1 country.

Alok SharmaDepartment of Neurosurgery, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Rohit KulkarniReeLabs Pvt. Ltd Mumbai, Maharashtra, India.
Hemangi SaneDepartment of Research & Development, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
Nilkanth AwadDepartment of Pulmonary Medicine, LTMG Hospital and LTM Medical College Sion, Mumbai, Maharashtra, India.
Abhijit BopardikarReeLabs Pvt. Ltd Mumbai, Maharashtra, India.
Anagha JoshiDepartment of Radiology, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Sujata BawejaDepartment of Microbiology, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Mohan JoshiDean, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Chandra VishwanathanReeLabs Pvt. Ltd Mumbai, Maharashtra, India.
Nandini GokulchandranDepartment of Medical Services and Clinical Research, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
Prerna BadheDepartment of Regenerative Laboratory, NeuroGen Brain and Spine Institute Seawoods, Navi Maharashtra, India.
Mazhar KhanDepartment of Neurosurgery, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India.
Amruta ParanjapeDepartment of Research & Development, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
Pooja KulkarniDepartment of Research & Development, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
Arjun K MethalDepartment of Research & Development, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India.
Neurogen Brain & Spine Institute · INLokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage.

methodPhase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed.

resultsNo adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention.

conclusionAdministration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175.

Indexed as

COVID-19cytokine stormmesenchymal stem cellsplacentaumbilical cord

Identifiers

PMID35873716
PMCPMC9301142
OpenAlexW4210704984

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.