Evidence map›Paper›PMID 37583846›Full record

Trial reportWorld journal of clinical cases2023

Safety evaluation of human umbilical cord-mesenchymal stem cells in type 2 diabetes mellitus treatment: A phase 2 clinical trial.

Xiao-Fen Lian, Dong-Hui Lu, Hong-Li Liu, Yan-Jing Liu, Yang Yang, Yuan Lin, Feng Xie, Cai-Hao Huang, Hong-Mei Wu, Ai-Mei Long and 5 more

Open access · diamondAbstract readClinical Trial
In one paragraph

Trial report in World journal of clinical cases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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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

15 authors at 3 institutions in 1 country.

Xiao-Fen LianDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Dong-Hui LuDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Hong-Li LiuDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Yan-Jing LiuDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Yang YangDepartment of Endocrinology, Huizhou Central People's Hospital, Huizhou 516000, Guangdong Province, China.
Yuan LinDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Feng XieDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Cai-Hao HuangDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Hong-Mei WuDepartment of Endocrinology, Longgang District Central Hospital of Shenzhen, Shenzhen 518000, Guangdong Province, China.
Ai-Mei LongDepartment of Endocrinology, Longgang District Central Hospital of Shenzhen, Shenzhen 518000, Guangdong Province, China.
Chen-Jun HuiDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Yu ShiDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Yun ChenDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Yun-Feng GaoDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China.
Fan ZhangDepartment of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. bjdxszyynfm@163.com.
Peking University Shenzhen Hospital · CNLonggang Central Hospital · CNHuizhou Central People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgressive pancreatic β cell dysfunction is a fundamental aspect of the pathology underlying type 2 diabetes mellitus (T2DM). Recently, mesenchymal stem cell (MSC) transplantation has emerged as a new therapeutic method due to its ability to promote the regeneration of pancreatic β cells. However, current studies have focused on its efficacy, and there are few clinical studies on its safety.

aimTo evaluate the safety of human umbilical cord (hUC)-MSC infusion in T2DM treatment.

methodsAn open-label and randomized phase 2 clinical trial was designed to evaluate the safety of hUC-MSC transplantation in T2DM in a Class A hospital. Ten patients in the placebo group received acellular saline intravenously once per week for 3 wk. Twenty-four patients in the hUC-MSC group received hUC-MSCs (1 × 10

resultsNo serious adverse events were observed during the 24-wk follow-up. Four patients (16.7%) in the hUC-MSC group experienced transient fever, which occurred within 24 h after the second or third infusion; this did not occur in any patients in the placebo group. One patient from the hUC-MSC group experienced hypoglycemic attacks within 1 mo after transplantation. Significantly lower lymphocyte levels (weeks 2 and 3) and thrombin coagulation time (week 2) were observed in the hUC-MSC group compared to those in the placebo group (all

conclusionOur study suggested that hUC-MSC transplantation has good tolerance and high safety in the treatment of T2DM. It can improve human immunity and inhibit lymphocytes. Coagulation function should be monitored vigilantly for abnormalities.

Indexed as

Cell transplantationHuman umbilical cord-mesenchymal stem cellsImmunityLymphocytesSafetyType 2 diabetes mellitus

Identifiers

PMID37583846
PMCPMC10424020
OpenAlexW4385440068

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.