Are there published clinical trials or peer-reviewed studies on gelatide efficacy and safety?
Executive summary
No documents in the provided reporting mention a compound or product named "gelatide"; therefore there is no direct evidence here of published clinical trials or peer‑reviewed studies on "gelatide" specifically (limitation of reporting) [1]. What is well documented in the sources is an extensive clinical and preclinical literature on gelatin and gelatin‑based medical products—ranging from randomized trials and systematic reviews of gelatin as a plasma expander to early clinical work on gelatin biomaterials and gelatin microspheres—some of which report safety concerns that warrant caution [1] [2] [3].
1. What the record actually contains: gelatin, not “gelatide”
None of the supplied sources reference a substance called "gelatide"; they instead discuss gelatin in multiple roles—colloid plasma expanders, supplements for collagen synthesis, gelatin‑based drug delivery systems, wound‑healing scaffolds, and gelatin microspheres used in embolization—so any claim about "gelatide" cannot be confirmed from this reporting [3] [4] [5].
2. Large syntheses and safety red flags for gelatin as a plasma expander
High‑level evidence includes systematic reviews and meta‑analyses examining gelatin-containing plasma expanders versus crystalloids or albumin; these reviews pooled dozens of studies (30 RCTs and additional nonrandomized and animal studies) and found signals of harm: a pooled risk ratio for mortality of ~1.15 (95% CI 0.96–1.38) and a markedly increased risk of anaphylaxis (RR ~3.01, 95% CI 1.27–7.14), with nonrandomized analyses suggesting increased hospital mortality and acute kidney injury or need for renal replacement therapy during gelatin intervention periods [1] [2] [6].
3. Clinical trial landscape beyond resuscitation: early‑stage and mixed results
Gelatin appears in other clinical contexts, but the work is largely small, early‑phase, or exploratory. Examples include a phase I evaluation of trisacryl gelatin microspheres for uterine artery embolization showing symptomatic benefit and acceptable safety in that context, clinical protocols testing gelatin hydrogel sheets to sustain platelet‑rich plasma for chronic ulcers, and randomized trials of gelatin sponges in oral surgery—outcomes that are promising but described by authors as preliminary and limited by sample size or follow‑up [7] [3] [5] [8].
4. Efficacy signals in niche uses and sports nutrition, but with caveats
Smaller randomized trials report potentially beneficial physiologic effects—e.g., vitamin C‑enriched gelatin increasing markers of collagen synthesis after exercise—which suggests mechanistic plausibility for tendon/ligament support and wound repair, and some nutritional supplement claims reference clinical trials of gelatin for joint pain or sleep; however, the trials are small, vary in dose and formulation, and are not a substitute for robust, large‑scale efficacy trials [4] [9].
5. Why uncertainty persists and where bias may hide
Authors of the systematic reviews stress that most gelatin studies are small, short‑term, and often use unsuitable controls, limiting reliability; industry or clinical habit may favour gelatin in some settings after restrictions on other colloids (e.g., hydroxyethyl starch), creating a substitution effect that could bias practice without solid safety data [2] [10] [11]. Consumer‑facing sites and supplement vendors sometimes overstate positive findings from limited trials (example: promotional health articles citing small trials) while the systematic reviews call for rigorous investigation [9] [1].
6. Bottom line for readers seeking evidence about “gelatide”
Based on the provided reporting, there are no identified peer‑reviewed clinical trials or systematic studies of a product called "gelatide"; the evidence available pertains to gelatin and its medical uses, where randomized trials and meta‑analyses exist but show mixed efficacy signals and notable safety concerns (anaphylaxis, possible renal harm) that require further high‑quality trials to resolve [1] [6] [3]. Any assertion about gelatide’s efficacy or safety would require separate, specific published studies not present in the supplied sources.