Evidence map›Paper›PMID 33422139›Full record

ArticleStem cell research & therapy2021

Intravitreal autologous mesenchymal stem cell transplantation: a non-randomized phase I clinical trial in patients with retinitis pigmentosa.

Aekkachai Tuekprakhon, Siripakorn Sangkitporn, Adisak Trinavarat, Aulia Rahmi Pawestri, Visit Vamvanij, Monchai Ruangchainikom, Panya Luksanapruksa, Phitchapa Pongpaksupasin, Areerat Khorchai, Acharaporn Dambua and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cell research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 3% 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.

NCT01531348 phase1completednot on this map

Feasibility and Safety of Adult Human Bone Marrow-Derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa

TypeinterventionalSponsorMahidol UniversityRan2012 to 2020Enrolled14ConditionsRetinitis PigmentosaArmsBM-MSC
NCT06242379 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Safety and Efficacy Evaluation of Intravitreal Injection of GMP-compliant Bone Marrow Mesenchymal Stem Cell-derived Small Extracellular Vesicles in Patients With Retinitis Pigmentosa

TypeinterventionalSponsorMahidol UniversityRan2024 to 2027Enrolled15ConditionsRetinitis PigmentosaArmsGMP compliant-BM-MSC derived sEVs
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Global Treatment Approaches Part 1: Neuroprotection and Stem Cell Therapy.Advances in experimental medicine and biology · 2025
    Review
  17. Review
  18. Article
  19. Review
  20. 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 3 institutions in 2 countries.

Aekkachai TuekprakhonDepartment of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.
Siripakorn SangkitpornStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand.
Adisak TrinavaratDepartment of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.
Aulia Rahmi PawestriFaculty of Medicine, Universitas Brawijaya, Malang, Indonesia.
Visit VamvanijDepartment of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Monchai RuangchainikomDepartment of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Panya LuksanapruksaDepartment of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Phitchapa PongpaksupasinDepartment of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.
Areerat KhorchaiStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand.
Acharaporn DambuaStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand.
Patcharaporn BoonchuStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand.
Chonlada YodtupStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand.
Mongkol UiprasertkulDepartment of Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Somchai SangkitpornStem cell and Regenerative Medicine Center, Department of Medical Sciences, Ministry of Public Health, National Institute of Health, 88/7 Tivanon Road, Muang, Nonthaburi, 11000, Thailand. somchai.s@dmsc.mail.go.th.
La-Ongsri AtchaneeyasakulDepartment of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand. atchanee@hotmail.com.ORCID 0000-0002-5320-7123
Siriraj Hospital · THMinistry of Public Health · THUniversity of Brawijaya · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetinitis pigmentosa (RP) is a progressive inherited retinal disease with great interest for finding effective treatment modalities. Stem cell-based therapy is one of the promising candidates. We aimed to investigate the safety, feasibility, and short-term efficacy of intravitreal injection of bone marrow-derived mesenchymal stem cells (BM-MSCs) in participants with advanced stage RP.

methodsThis non-randomized phase I clinical trial enrolled 14 participants, categorized into three groups based on a single dose intravitreal BM-MSC injection of 1 × 10

resultsDuring the 12-month period, we noticed several mild and transient AEs. Interestingly, we found statistically significant improvements in the BCVA compared to baseline, although they returned to the baseline at 12 months. The VF and CST were stable, indicating no remarkable disease progression. We followed 12 participants beyond the study period, ranging from 1.5 to 7 years, and observed one severe but manageable AE at year 3.

conclusionIntravitreal injection of BM-MSCs appears to be safe and potentially effective. All adverse events during the 12-month period required observation without any intervention. For the long-term follow-up, only one participant needed surgical treatment for a serious adverse event and the vision was restored. An enrollment of larger number of participants with less advanced RP and long-term follow-up is required to evaluate the safety and efficacy of this intervention.

trial registrationClinicalTrials.gov, NCT01531348 . Registered on February 10, 2012.

Indexed as

Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationRetinitis PigmentosaHumansIntravitreal InjectionsRetinaTransplantation, AutologousInherited retinal diseasesMesenchymal stem cellPhase I clinical trialRetinitis pigmentosa (RP)Stem cell therapy

Identifiers

PMID33422139
PMCPMC7796606
OpenAlexW3119645677

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.