Trial reportStem cell research & therapy2020
Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells-first phase I/II human clinical study.
Trial report in Stem cell research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01981330 (Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled 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.
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.
Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Efficacy of platelet-rich plasma (PRP) in benign vocal fold lesions: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024Pooled it
- An open phase I/IIa study evaluating safety, patient-reported outcomes and voice function after surgery, local administration of mesenchymal stromal cells and voice training in patients with vocal fold scarring and dysphonia.Stem cell research & therapy · 2026Trial
- SPHERpower: MSC spheroid-based bioequivalent lead to the efficient restoration of the scarred vocal folds.Stem cell research & therapy · 2026Article
- Vocal Fold Scar Treatment via Controlled Dexamethasone Delivery With a Light-Activatable Implant.The Laryngoscope · 2026Article
- Single Platelet Rich Plasma Glottic Injections in Vocal Pathology Demonstrate Long Term Benefits.The Laryngoscope · 2026Article
- Regenerative Strategies for Vocal Fold Repair Using Injectable Materials.Biomimetics (Basel, Switzerland) · 2025Review
- Platelet Rich plasma injection of the vocal folds in benign vocal pathologies.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024Article
- Drug delivery systems for wound healing treatment of upper airway injury.Expert opinion on drug delivery · 2024Review
- Cell-Based Outer Vocal Fold Replacement Both Treats and Prevents Vocal Fold Scarring in Rabbits.The Laryngoscope · 2024Article
- Vocal fold restoration after scarring: biocompatibility and efficacy of an MSC-based bioequivalent.Stem cell research & therapy · 2023Article
- Platelet-rich plasma in treatment of scar, atrophy, and sulcus: Short- and long-term results.Laryngoscope investigative otolaryngology · 2023Article
- Tissue-engineered vocal fold replacement in swine: Methods for functional and structural analysis.PloS one · 2023Article
- Intracordal injection therapy for vocal fold scarring: Steroid versus basic fibroblast growth factor.Laryngoscope investigative otolaryngology · 2022Article
- In vivo hamster cheek pouch subepithelial ablation, biomaterial injection, and localization: pilot study.Journal of biomedical optics · 2022Article
- Clinical application of mesenchymal stem cell in regenerative medicine: a narrative review.Stem cell research & therapy · 2022Review
- Stem cell therapy for vocal fold regeneration after scarring: a review of experimental approaches.Stem cell research & therapy · 2022Review
- Mesenchymal Stem/Stromal Cells in Progressive Fibrogenic Involvement and Anti-Fibrosis Therapeutic Properties.Frontiers in cell and developmental biology · 2022Review
- Intestinal Fibrosis in Inflammatory Bowel Disease and the Prospects of Mesenchymal Stem Cell Therapy.Frontiers in immunology · 2022Review
- Review
- Achievements and Challenges in Transplantation of Mesenchymal Stem Cells in Otorhinolaryngology.Journal of clinical medicine · 2021Review
Corrections and comments
- Commented on by
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVocal fold (VF) scarring, caused by surgery or inflammation, often results in severe voice problems or aphonia. Effective lasting treatment is lacking. Previous in vitro and in vivo animal studies reported positive effects on VF scar resolution with mesenchymal stromal cell (MSC) implantation. The principal aim of this study was to examine safety aspects and secondly treatment efficacy vocal fold function in patients with VF scarring and severe voice problems.
methodsIn this open-label phase I/II study, 16 patients were treated with surgical scar resection followed by injection of autologous MSCs (0.5-2 × 10
resultsNo SAE or minor side effects were reported. Video ratings of VF vibrations and digitized analysis of HSL and PTP were significantly improved for 62-75% of the patients (depending on parameter). Two patients showed deteriorated VF vibrations, but improved PTP. VHI was significantly improved in 8 patients, with the remaining experiencing no significant change.
conclusionsThe results indicate that local injection of autologous MSC into scarred VFs with severe voice problems may offer a safe and feasible therapeutic option. VF vibration and elasticity were improved in approximately two thirds of treated patients. This clinical study is registered in clinicaltrials.gov (ID: NCT01981330). Retrospective registration of first patient (20130511). https//: register.clinicaltrials.gov/.
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Identifiers
What OpenQuestion holds
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.