Are there published clinical trials or peer-reviewed studies assessing gelatide's safety and efficacy?

Checked on December 9, 2025
Disclaimer: Factually can make mistakes. Please verify important information or breaking news. Learn more.

Executive summary

There are many published studies and clinical trials about gelatin-based products and gelatin as a medical material, but no source in the provided list names or studies a product called “gelatide.” Systematic reviews and randomized trials exist for gelatin solutions (e.g., volume resuscitation) and for gelatin used in drug delivery or biomaterials, yet authors repeatedly say gelatin’s safety and efficacy remain incompletely established in several settings [1] [2] [3].

1. No documented studies of “gelatide” in the supplied record

A focused read of the supplied search results finds multiple clinical trials and peer‑reviewed papers about gelatin and gelatin‑based materials (hydrogels, capsules, microspheres) but none that mention a product, compound, or investigational agent named “gelatide.” The available sources do not mention clinical trials or peer‑reviewed studies specifically assessing “gelatide” (not found in current reporting).

2. What the literature does show: gelatin hydrogels and GelMA in preclinical and early translational work

Peer‑reviewed engineering and materials science journals report extensive preclinical work on gelatin derivatives such as gelatin methacryloyl (GelMA) used for cartilage, bone and soft‑tissue scaffolds; many papers describe in vitro and animal studies and call for in vivo validation and clinical translation (e.g., cartilage repair with GelMA composites and in‑vivo tracking of gelatin hydrogels) [4] [5]. Reviews likewise portray gelatin as a promising biomaterial but note translational challenges [6].

3. Clinical use and trials exist for gelatin formulations — but in defined contexts

There are randomized trials and registry‑listed trials investigating gelatin solutions as plasma expanders and for fluid resuscitation (for example, protocols and trial reports such as the GENIUS trial and other clinical studies of balanced gelatine solutions in sepsis) [7] [8]. Vaginal administration of gelatin capsules carrying probiotics has been tested in a double‑blind randomized safety trial [9]. Gelatin nanoparticles and microspheres have undergone some clinical evaluation in drug‑delivery contexts, though the clinical portfolio is still limited [10] [3].

4. Safety and efficacy remain contested and incompletely defined

Systematic reviews and meta‑analyses conclude that the safety and efficacy of gelatin in some medical uses cannot be reliably assessed based on existing trials. A large systematic review found elevated risk ratios for anaphylaxis after gelatin administration (RR ~3.01) and inconclusive but concerning signals for mortality, renal injury and transfusion needs [1] [11]. Earlier meta‑analyses similarly concluded that despite decades of use, evidence is insufficient to settle gelatin’s risk/benefit in several clinical settings [2] [12].

5. Why the gap matters if you’re searching for “gelatide” data

The literature shows active research on gelatin and derivative platforms, with both clinical trials (e.g., fluid resuscitation trials, vaginal capsule safety trials) and ongoing translational work [8] [9] [5]. But if “gelatide” is a proprietary name, a new derivative, or a recent product, the supplied sources do not document it. That gap could reflect (a) a naming mismatch between what you searched and how studies are indexed, (b) a truly new or proprietary agent not yet published, or (c) a non‑existent or misremembered name — available sources do not mention “gelatide.”

6. Competing perspectives in the sources: promise vs. evidentiary caution

Materials science and tissue‑engineering papers present gelatin derivatives as promising platforms for regenerative medicine and drug delivery and report encouraging in vitro and animal data [4] [5] [6]. In contrast, clinical evidence syntheses urge caution: randomized trials are often small, follow‑up short, heterogeneous and insufficient to fully assess safety signals such as anaphylaxis, renal injury and effects on mortality [1] [2] [13]. Both perspectives come from peer‑reviewed literature cited above.

7. If you want to proceed: what to search or request next

To find definitive evidence on “gelatide,” request or search for (a) exact regulatory or trade names, (b) the active chemical name or CAS number, (c) company press releases or clinicaltrials.gov identifiers tied to that name. The current set of sources documents gelatin and GelMA research and clinical trials but does not show peer‑reviewed clinical trials or safety/efficacy assessments for “gelatide” specifically (not found in current reporting).

Want to dive deeper?
What is gelatide and how does it work biologically?
Which journals have published studies on gelatide safety since 2020?
Are there completed randomized controlled trials evaluating gelatide efficacy in humans?
What adverse events have been reported for gelatide in clinical studies?
How does gelatide compare to standard treatments in head-to-head trials?