TABLE 3.
Summary of recruiting, enrolling, active clinical trials using novel hydrogel biomaterials or dosage forms.
| Name (sponsor company or university) | Indication | Route of administration | Hydrogel formulation | Drug delivered | ClinicalTrials.gov identifier (trial phase) |
|---|---|---|---|---|---|
| First nanogel/microgel based delivery systems as combination products | |||||
| Embozene microspheres (NYU Langone Health) | Osteoarthritis | Intraarticular injection | Polyzene‐F microspheres | No | NCT04379700 (NA) |
| OptiSphere (University of Pittsburgh) | Knee osteoarthritis | Intraarterial injection | Microspheres (unknown material) | No | NCT04951479 (NA) |
| Hollow gold and silver alloy cuprous oxide shell nano‐shell hydrogel (Zhejang University) | Ulcerative keratitis, antibiotic resistance, photothermal therapy | Topical application | Nanogel suspension | No | NCT05268718 (early Ph I) |
| LifePearl (Grupo Espanol Multidisciplinario del Cancer Digestivo) | Metastatic colorectal cancer, liver metastasis | Intraarterial injection | PEG microgel suspension | Yes, irinotecan | NCT04595266 (Ph II) |
| CartiLife (Biosolution Co., Ltd.) | Articular cartilage defect, articular cartilage degeneration | Intraarticular injection | Fibrin microsphere | Yes, chondrocytes | NCT05051332 (Ph III) |
| Gel biologics + cell combination products | |||||
| SygeLIX‐F, SygeLIX‐G (TBF Genie Tissulaire) | Anal fistula | Implant via internal orifice | Bulk Wharton's Jelly gel plug | Yes, stem cells | NCT05638139 (Ph I) |
| TumoCure (IntraGel Therapeutics) | Head and neck cancer | Intratumoral injection | Bulk polymeric gel | Yes, cisplatin | NCT05200650 (Ph I) |
| BioVAT (University Medical Center Coettingen) | Heart failure | Implant in ventricular myocardium | Bulk collagen hydrogel with iPSC‐derived cardiomyocytes | Yes, cardiomyocytes | NCT04396899 (Ph I, Ph II) |
| Placental mesenchymal stem cells on dural ECM (California Institute for Regenerative Medicine) | Myelomeningocele | Topical application | Bulk dural graft ECM hydrogel | Yes, mesenchymal stem cells | NCT04652908 (Ph I, Ph II) |
| ALLO‐ACS‐DFU (Anterogen Co., Ltd.) | Diabetic foot ulcer | Topical application | Hydrogel SHEET dressing | Yes, allogenic mesenchymal stem cells | NCT03754465 (Ph II) |
| DBI‐001, DBI‐002 (DermBiont, Inc.) | Tinea pedis | Topical application | Unknown aqueous gel | Yes, microbe | NCT05493488 (Ph II) |
| TTAX01 (Tissue Tech Inc.) | Non‐healing diabetic foot ulcer | Topical application | Decellularized human placental umbilical cord tissue | No | NCT04450693 (Ph III) |
| TTAX01 (Tissue Tech Inc.) | Non‐healing diabetic foot ulcer | Topical application | Decellularized human placental umbilical cord tissue | No | NCT04176120 (Ph III) |
| ArthoFLEX ECM scaffold (Cleveland Clinic) | Rotator cuff tear | Implant via arthroscopic procedure | Bulk ECM hydrogel | No | NCT03551509 (Ph IV) |
| New polymers/materials (fewer than two trials and no approved products) | |||||
| Chitodex Gel (St. Louis University) | Chronic rhinosinusitis | Topical application in nasal cavity | Chitosan and dextran | No | NCT05083741 (not given) |
| CartRevive (Hy2Care BV, Avania, UMC Utrecht) | Cartilage damage | Intraoperative injection in knee | Dextran + hyaluronic acid | No | NCT05186935 (NA) |
| Multi‐Gyn ActiGel (BioClin BV, Avania, Karo Pharma AB) | Bacterial vaginoses | Topical application to vagina | Galactoarabinan polyglucoronic acid crosspolymer | No | NCT04807842 (NA) |
| Aquacryl (Ain Shams Maternity Hospital) | Early abortion | Implant in cervical canal | Poly(acrylonitrile) | No | NCT05147857 (NA) |
| Condrotide® (Mastelli S.r.I, Latis S.r.I.) | Meniscus tear, meniscus lesion | Intraarticular and intrameniscal injection | Polynucleotide | No | NCT05322005 (NA) |
| Plenhyage® (I.R.A. Istituto Ricerche Applicate S.p.A.|Opera CRO, a TIGERMED Group Company) | Cicatrix, lipodystrophy, plaque | Intradermal injection | Polynucleotides (PDRN) of animal origin (fish) | No | NCT05239117 (NA) |
| Emdogain® FL (Aristotle University of Thessaloniki) | Periodontal Disease, AVDC Stage 3 and 4 | Periodontal implant | Propylene glycol alginate and Porcine enamel matrix derivative | No | NCT05541614 (NA) |
| SMI‐01 (Sofregen Medical, Inc., Symbio, LLC). | Nasolabial fold, cheek augmentation | Intradermal injection | Silk | No | NCT04534660 (NA) |
| Particulate xenograft erythropoietin gel (Ain Shams University) | Periodontal bone loss | Periodontal implant | Erythropoietin and carboxymethylcellulose | Yes, particulate xenograft | NCT05360511 (Early Ph I) |
| PRO‐165 (Laboratorios Sophia S.A de C.V. | Dry eye syndromes | Topical application to eye | Chondroitin sulfate and hyaluronic acid | No | NCT03697876 (Ph I) |
| UGN‐102 (UroGen Pharma Ltd.) | Bladder cancer, urothelial carcinoma | Intravesicular injection (into bladder via catheter) | PEO/PPO triblock copolymer | Yes, mitomycin | NCT05243550 (Ph III) |
| UGN‐102 (UroGen Pharma Ltd.) | Bladder cancer, urothelial carcinoma | Intravesicular injection (into bladder via catheter) | PEO/PPO triblock copolymer | Yes, mitomycin | NCT05136898 (Ph III) |
| Hydrotac (Centre Francois Baclesse, Ministry of Health, France) | Head and neck cancer | Topical application to skin | Polyurethane | No | NCT01520701 (Ph III) |
| Chitosan‐based erythropoietin gel (Ain Shams University) | Erythropoietin recession | Topical application to gingiva | Chitosan and beta glycerophosphate | Yes, erythropoetin | NCT05683782 (Ph 4) |
Note: Trials are organized by their category of technical novelty.