Trial reportHeart and vessels2016
Safety and efficacy of sustained release of basic fibroblast growth factor using gelatin hydrogel in patients with critical limb ischemia.
Trial report in Heart and vessels, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed.
- Hydrogel Microspheres as Versatile Platforms for Biomedical Research: Design, Properties, and Applications.MedComm · 2025Review
- Angiogenesis Using Recombinant Basic Fibroblast Growth Factor With Atelocollagen in Normal and Hind Limb Ischemia Models.Circulation reports · 2025Article
- Hydrogel-based cardiac repair and regeneration function in the treatment of myocardial infarction.Materials today. Bio · 2024Review
- Protein-based nanoparticles for therapeutic nucleic acid delivery.Biomaterials · 2024Review
- A biomimetic approach to modulating the sustained release of fibroblast growth factor 2 from fibrin microthread scaffolds.Exploration of biomat-x · 2024Article
- Current Trends in Gelatin-Based Drug Delivery Systems.Pharmaceutics · 2023Review
- Tissue engineering modalities in skeletal muscles: focus on angiogenesis and immunomodulation properties.Stem cell research & therapy · 2023Review
- Therapeutic angiogenesis and tissue revascularization in ischemic vascular disease.Journal of biological engineering · 2023Review
- Hydrogels and Hydrogel Nanocomposites: Enhancing Healthcare through Human and Environmental Treatment.Advanced healthcare materials · 2022Review
- Gene Therapy of Chronic Limb-Threatening Ischemia: Vascular Medical Perspectives.Journal of clinical medicine · 2022Review
- Overcoming ischemia in the diabetic foot: Minimally invasive treatment options.World journal of diabetes · 2021Review
- Stabilisation of Recombinant Human Basic Fibroblast Growth Factor (FGF-2) against Stressors Encountered in Medicinal Product Processing and Evaluation.Pharmaceutics · 2021Article
- Therapeutic Biomaterial Approaches to Alleviate Chronic Limb Threatening Ischemia.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021Review
- Bioengineering strategies for the treatment of peripheral arterial disease.Bioactive materials · 2021Review
- Stable Fibroblast Growth Factor 2 Dimers with High Pro-Survival and Mitogenic Potential.International journal of molecular sciences · 2020Article
- Basic fibroblast growth factor attenuates left-ventricular remodeling following surgical ventricular restoration in a rat ischemic cardiomyopathy model.General thoracic and cardiovascular surgery · 2020Article
- Applicability of Transcutaneous Oxygen Tension Measurement in the Assessment of Chronic Limb-Threatening Ischemia.Angiology · 2020Article
- Controlled delivery of basic fibroblast growth factor (bFGF) using acoustic droplet vaporization stimulates endothelial network formation.Acta biomaterialia · 2019Article
- Toward Regeneration of the Heart: Bioengineering Strategies for Immunomodulation.Frontiers in cardiovascular medicine · 2019Review
- Sustained release of basic fibroblast growth factor using gelatin hydrogel improved left ventricular function through the alteration of collagen subtype in a rat chronic myocardial infarction model.General thoracic and cardiovascular surgery · 2018Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As a form of therapeutic angiogenesis, we sought to investigate the safety and efficacy of a sustained-release system of basic fibroblast growth factor (bFGF) using biodegradable gelatin hydrogel in patients with critical limb ischemia (CLI). We conducted a phase I-IIa study that analyzed 10 CLI patients following a 200-μg intramuscular injection of bFGF-incorporated gelatin hydrogel microspheres into the ischemic limb. Primary endpoints were safety and transcutaneous oxygen pressure (TcO2) at 4 and 24 weeks after treatment. During the follow-up, there was no death or serious procedure-related adverse event. After 24 weeks, TcO2 (28.4 ± 8.4 vs. 46.2 ± 13.0 mmHg for pretreatment vs after 24 weeks, p < 0.01) showed significant improvement. Regarding secondary endpoints, the distance walked in 6 min (255 ± 105 vs. 318 ± 127 m, p = 0.02), the Rutherford classification (4.4 ± 0.5 vs. 3.1 ± 1.4, p = 0.02), the rest pain scale (1.7 ± 1.0 vs. 1.2 ± 1.3, p = 0.03), and the cyanotic scale (2.0 ± 1.1 vs. 0.9 ± 0.9, p < 0.01) also showed improvement. The blood levels of bFGF were within the normal range in all patients. A subanalysis of patients with arteriosclerosis obliterans (n = 7) or thromboangiitis obliterans (Buerger's disease) (n = 3) revealed that TcO2 had significantly improved in both subgroups. TcO2 did not differ between patients with or without chronic kidney disease. The sustained release of bFGF from biodegradable gelatin hydrogel may offer a safe and effective form of angiogenesis for patients with CLI.
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Identifiers
25861983What Socratic 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 Socratic graph.