Evidence map›Paper›PMID 38965462›Full record

ArticleBasic and clinical andrology2024

Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial.

Saddam Al Demour, Sofia Adwan, Hanan Jafar, Hussam Alhawari, Abdalla Awidi

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Basic and clinical andrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02945462 (The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 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.

NCT02945462 phase1completednot on this map

The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients

TypeinterventionalSponsorUniversity of JordanRan2013 to 2016Enrolled4ConditionsErectile DysfunctionArmsautologous mesenchymal stem cells
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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

5 authors.

Saddam Al DemourDepartment of Special Surgery, Division of Urology, School of Medicine, The University of Jordan, Amman, 11942, Jordan. saldemour@ju.edu.jo.ORCID http://orcid.org/0000-0003-4044-0927
Sofia AdwanCell Therapy Center, The University of Jordan, 11942, Amman, Jordan.
Hanan JafarCell Therapy Center, The University of Jordan, 11942, Amman, Jordan.
Hussam AlhawariDepartment of Internal Medicine, School of Medicine, The University of Jordan, 11942, Amman, Jordan.
Abdalla AwidiCell Therapy Center, The University of Jordan, 11942, Amman, Jordan. abdalla.awidi@gmail.com.

Funding

Deanship of Scientific Research, University of Jordan (No. 1572)
6 · The paper itself

Abstract

backgroundRecently we reported results of phase 1 pilot clinical trial of 2 consecutive intracavernous (IC) injection of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (DM-ED). In phase 2 of this study our aim is to evaluate long term safety and efficacy of IC injections of BM-MSC on additional eight patients with DM-ED.

resultsEach patient received 2 consecutive IC injections of BM-MSC and evaluated at 1, 3, 6, 12, and 24-month time points. Primary outcome was the tolerability and safety of stem cells therapy (SCT), while the secondary outcome was improvement of erectile function (EF) as assessed using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS) questionnaires, and Color Duplex Doppler Ultrasound (CDDU). IC injections of BM-MSCs was safe and well-tolerated. Minor local and short-term adverse events related to the bone marrow aspiration and IC injections were observed and treated conservatively. There were significant improvement in mean IIEF-5, EHS, all over the follow-up time points in comparison to the baseline. At 24-month follow up there were significant decline in the mean IIEF-5, and EHS compared to the baseline. The mean basal and 20-min peak systolic velocity was significantly higher at 3-month after the IC injections compared to baseline.

conclusionsThis phase 2 clinical trial confirmed that IC injections of BM-MSC are safe and improve EF. The decline in EF over time suggests a need for assessing repeated injections. CLINICAL

trial registrationNCT02945462.

Indexed as

Bone marrow-derived mesenchymal stem cellsDiabetic erectile dysfunctionErectile dysfunctionStem cellsStem cells therapy

Identifiers

PMID38965462
PMCPMC11225209

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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.