Trial reportStem cells translational medicine2017
Administration of Adult Human Bone Marrow-Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger's Disease: Phase II Study Report Suggests Clinical Efficacy.
Trial report in Stem cells translational medicine, 2017. 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 48 papers, 3 of them syntheses 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.
An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease.
Who cites it
48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Stem cell therapy approaches for non-malignant diseases & non-haematological diseases in India: A systematic review.The Indian journal of medical research · 2024Pooled it
- Autologous cells derived from different sources and administered using different regimens for 'no-option' critical lower limb ischaemia patients.The Cochrane database of systematic reviews · 2018Pooled it
- Optimizing dose and delivery route in mesenchymal stromal cells (MSCs)-based therapy: A systematic review of their implications for clinical efficacy.Cell transplantationPooled it
- Label extension, single-arm, phase III study shows efficacy and safety of stempeucel® in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease.Stem cell research & therapy · 2023Trial
- Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease.Stem cells translational medicine · 2021Trial
- Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.Stem cell research & therapy · 2020Trial
- Review
- Analgesic strategies for ischaemic pain in chronic limb-threatening ischaemia: a systematic review and meta-analysis.Pain reports · 2026Review
- Two years efficacy and safety outcomes of using allogeneic, pooled mesenchymal stromal cells for osteoarthritis of knee in a double-blind randomized placebo-controlled phase 3 study.Osteoarthritis and cartilage open · 2026Article
- Tissue factor and regenerative medicine: shaping cell and extracellular vesicle-based therapeutic approaches.Frontiers in cell and developmental biology · 2026Review
- Pooling umbilical cord-mesenchymal stromal cells derived from selected multiple donors reduces donor-dependent variability and improves their immunomodulatory properties.Stem cell research & therapy · 2025Article
- Investigational New Drug-enabling studies to use genetically modified mesenchymal stromal cells in patients with critical limb ischemia.Stem cells translational medicine · 2025Article
- Mesenchymal stromal cell therapy (REGENACIPStem cell research & therapy · 2024Review
- Mesenchymal stem cell therapy in eosinophilic granulomatosis with polyangiitis-related lower limb gangrene: a case report.Stem cell research & therapy · 2024Article
- Advantages of pooling of human bone marrow-derived mesenchymal stromal cells from different donors versus single-donor MSCs.Scientific reports · 2024Article
- Bioengineering Cell Therapy for Treatment of Peripheral Artery Disease.Arteriosclerosis, thrombosis, and vascular biology · 2024Review
- A programmable arthritis-specific receptor for guided articular cartilage regenerative medicine.bioRxiv : the preprint server for biology · 2024Article
- Wharton's jelly mesenchymal stem cells transplantation for critical limb ischemia in patients with type 2 diabetes mellitus: a preliminary report of phase I clinical trial.Cell and tissue research · 2024Article
- The issue of heterogeneity of MSC-based advanced therapy medicinal products-a review.Frontiers in cell and developmental biology · 2024Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Critical limb ischemia (CLI) due to Buerger's disease is a major unmet medical need with a high incidence of morbidity. This phase II, prospective, nonrandomized, open-label, multicentric, dose-ranging study was conducted to assess the efficacy and safety of i.m. injection of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (BMMSC) in CLI due to Buerger's disease. Patients were allocated to three groups: 1 and 2 million cells/kg body weight (36 patients each) and standard of care (SOC) (18 patients). BMMSCs were administered as 40-60 injections in the calf muscle and locally, around the ulcer. Most patients were young (age range, 38-42 years) and ex-smokers, and all patients had at least one ulcer. Both the primary endpoints-reduction in rest pain (0.3 units per month [SE, 0.13]) and healing of ulcers (11% decrease in size per month [SE, 0.05])-were significantly better in the group receiving 2 million cells/kg body weight than in the SOC arm. Improvement in secondary endpoints, such as ankle brachial pressure index (0.03 [SE, 0.01] unit increase per month) and total walking distance (1.03 [SE, 0.02] times higher per month), were also significant in the group receiving 2 million cells/kg as compared with the SOC arm. Adverse events reported were remotely related or unrelated to BMMSCs. In conclusion, i.m. administration of BMMSC at a dose of 2 million cells/kg showed clinical benefit and may be the best regimen in patients with CLI due to Buerger's disease. However, further randomized controlled trials are required to confirm the most appropriate dose. Stem Cells Translational Medicine 2017;6:689-699.
Indexed as
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.