Trial reportJournal of translational medicine2013
A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia.
Trial report in Journal of translational medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 110 papers, 8 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.
A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)
A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
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
110 citing papers in PubMed, 8 syntheses or guidelines pooled it, 221 citations in OpenAlex.
- Autologous cell therapy for ischemic diabetic foot: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome.Acta diabetologica · 2025Pooled it
- Stem cell therapy approaches for non-malignant diseases & non-haematological diseases in India: A systematic review.The Indian journal of medical research · 2024Pooled it
- Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia.The Cochrane database of systematic reviews · 2022Pooled it
- Pooled it
- Autologous stem cell therapy for peripheral arterial disease: a systematic review and meta-analysis of randomized controlled trials.Stem cell research & therapy · 2019Pooled 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
- Local intramuscular transplantation of autologous mononuclear cells for critical lower limb ischaemia.The Cochrane database of systematic reviews · 2014Pooled 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
- Long-Term Outcomes of BMMSC Compared with BMMNC for Treatment of Critical Limb Ischemia and Foot Ulcer in Patients with Diabetes.Cell transplantation · 2019Trial
- Autologous Granulocyte Colony-Stimulating Factor-Mobilized Peripheral Blood CD34 Positive Cell Transplantation for Hemodialysis Patients with Critical Limb Ischemia: A Prospective Phase II Clinical Trial.Stem cells translational medicine · 2018Trial
- Trial
- 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.Stem cells translational medicine · 2017Trial
- Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel®): preclinical and clinical trial in osteoarthritis of the knee joint.Arthritis research & therapy · 2016Trial
- Characteristics of responders to autologous bone marrow cell therapy for no-option critical limb ischemia.Stem cell research & therapy · 2016Trial
- Small extracellular vesicles mediate the antihyperalgesic effect of bone marrow stromal cells: the role of "priming".bioRxiv : the preprint server for biology · 2026Article
- 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
- Mesenchymal stromal cell therapy (REGENACIPStem cell research & therapy · 2024Review
50 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPeripheral vascular disease of the lower extremities comprises a clinical spectrum that extends from no symptoms to presentation with critical limb ischemia (CLI). Bone marrow derived Mesenchymal Stem Cells (BM- MSCs) may ameliorate the consequences of CLI due to their combinatorial potential for inducing angiogenesis and immunomodulatory environment in situ. The primary objective was to determine the safety of BM- MSCs in patients with CLI.
methodsProspective, double blind randomized placebo controlled multi-center study was conducted in patients with established CLI as per Rutherford classification in category II-4, III-5, or III-6 with infra-inguinal arterial occlusive disease and were not suitable for or had failed revascularization treatment. The primary end point was incidence of treatment - related adverse events (AE). Exploratory efficacy end points were improvement in rest pain, increase in Ankle Brachial Pressure Index (ABPI), ankle pressure, healing of ulcers, and amputation rates. Twenty patients (BM-MSC: Placebo = 1:1) were administered with allogeneic BM-MSCs at a dose of 2 million cells/kg or placebo (PlasmaLyte A) at the gastrocnemius muscle of the ischemic limb.
resultsImprovement was observed in the rest pain scores in both the arms. Significant increase in ABPI and ankle pressure was seen in BM-MSC arm compared to the placebo group. Incidence of AEs in the BM-MSC arm was 13 vs. 45 in the placebo arm where as serious adverse events (SAE) were similar in both the arms (5 in BM-MSC and 4 in the placebo group). SAEs resulted in death, infected gangrene, amputations in these patients. It was observed that the SAEs were related to disease progression and not related to stem cells.
conclusionBM-MSCs are safe when injected IM at a dose of 2 million cells/kg body weight. Few efficacy parameters such as ABPI and ankle pressure showed positive trend warranting further studies.
trial registrationNIH website (http://www.clinicaltrials.gov/ct2/show/NCT00883870).
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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.