Evidence map›Paper›PMID 36069837›Full record

ArticleStem cells translational medicine2022

Safety of Human Embryonic Stem Cell-derived Mesenchymal Stem Cells for Treating Interstitial Cystitis: A Phase I Study.

Jung Hyun Shin, Chae-Min Ryu, Hwan Yeul Yu, Juhyun Park, Ah Reum Kang, Jeong Min Shin, Ki-Sung Hong, Eun Young Kim, Hyung-Min Chung, Dong-Myung Shin and 1 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Stem cells translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
7.1field-weighted citation impact, top 2% 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.

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

25 citing papers in PubMed, 33 citations in OpenAlex.

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  20. [Interstitial cystitis/bladder pain syndrome (IC/BPS)].Urologie (Heidelberg, Germany) · 2023
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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

11 authors at 4 institutions in 1 country.

Jung Hyun ShinDepartment of Urology, Ewha Womans University, Mokdong Hospital, Seoul, Korea.
Chae-Min RyuDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Hwan Yeul YuDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Juhyun ParkDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ah Reum KangMirae Cell Bio Co., Ltd., Seoul, Korea.
Jeong Min ShinMirae Cell Bio Co., Ltd., Seoul, Korea.
Ki-Sung HongMirae Cell Bio Co., Ltd., Seoul, Korea.
Eun Young KimMirae Cell Bio Co., Ltd., Seoul, Korea.
Hyung-Min ChungMirae Cell Bio Co., Ltd., Seoul, Korea.
Dong-Myung ShinDepartment of Biomedical Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0002-0511-5750
Myung-Soo ChooDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0002-3293-4751
Ulsan College · KRCell Biotech (South Korea) · KREwha Womans University · KRKonkuk University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There are still no definite treatment modalities for interstitial cystitis (IC). Meanwhile, stem cell therapy is rising as potential alternative for various chronic diseases. This study aimed to investigate the safety of the clinical-grade mesenchymal stem cells (MSCs) derived from human embryonic stem cells (hESCs), code name MR-MC-01 (SNU42-MMSCs), in IC patients. Three female IC patients with (1) symptom duration >6 months, (2) visual pain analog scale (VAS) ≥4, and (3) one or two Hunner lesions <2 cm in-office cystoscopy within 1 month were included. Under general anesthesia, participants received cystoscopic submucosal injection of SNU42-MMSCs (2.0 × 107/5 mL) at the center or margin of Hunner lesions and other parts of the bladder wall except trigone with each injection volume of 1 mL. Follow-up was 1, 3, 6, 9, and 12 months postoperatively. Patients underwent scheduled follow-ups, and symptoms were evaluated with validated questionnaires at each visit. No SNU42-MMSCs-related adverse events including immune reaction and abnormalities on laboratory tests and image examinations were reported up to 12-month follow-up. VAS pain was temporarily improved in all subjects. No de novo Hunner lesions were observed and one lesion of the first subject was not identifiable on 12-month cystoscopy. This study reports the first clinical application of transurethral hESC-derived MSC injection in three patients with IC. hESC-based therapeutics was safe and proved to have potential therapeutic efficacy in IC patients. Stem cell therapy could be a potential therapeutic option for treating IC.

Indexed as

Cystitis, InterstitialHuman Embryonic Stem CellsMesenchymal Stem CellsFemaleHumansPainUrinary Bladderclinical trialembryonic stem cellHunner lesioninterstitial cystitismesenchymal stem cell

Identifiers

PMID36069837
PMCPMC9585946
OpenAlexW4295024358

What OpenQuestion holds

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LicenceCC BY-NC
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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 OpenQuestion graph.