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Clinical trials
catalyst calendar across sponsors →Studies where RCEL is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
13 interventional · 2 observational · 8 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical WoundsNCT06750809Reduction of Cost per Total Body Surface Area (TBSA)Randomized · Open-label · Treatment | Not applicable | Active, not recruiting | Device: PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA) | Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn, Partial Thickness Wounds | 40 | May 2026 | 2026-03-11 |
| Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness WoundsNCT06787690Time for Cohealyx to generate tissue capable of supporting definitive closureOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Cohealyx | Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound | 41 | 2026-02-10actual | 2026-03-12 |
| Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ CellsNCT05971381Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)Open-label · Treatment | Not applicable | Completed | Device: RECELL® Autologous Cell Harvesting Device | Vitiligo | 109 | 2024-07-30actual | 2025-02-06 |
| Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo LesionsNCT04547998results2023-09-21Incidence of ≥80% Study Area RepigmentationOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Control Intervention (UVB), Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB) | Vitiligo | 25 | 2022-06-28actual | 2024-05-24 |
| RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue ReconstructionNCT04091672results2023-09-21Incidence of Treatment Area HealingOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Procedure: Control Intervention (Conventional Autograft) · Device: Investigational Intervention (RECELL + more widely meshed autograft) | Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer, Cellulitis, Infection, Necrotizing Fasciitis, Gun Shot Wound | 65 | 2022-03-07actual | 2024-07-30 |
| Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo LesionsNCT04271501RepigmentationRandomized · Double-masked · Device feasibility | Not applicable | Terminatedsponsor's stated reason: Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions | Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB) · Device: RECELL 1:5 and Ultraviolet Lamp (UVB), RECELL 1:10 and Ultraviolet Lamp (UVB), RECELL 1:20 and Ultraviolet Lamp (UVB) | Vitiligo | 5 | 2021-08-24actual | 2023-03-14 |
| RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 YearsNCT03626701results2023-06-26Incidence of Index Burns With Day 10 HealingRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age). | Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device · Combination product: Mepilex® Ag Wound Dressing · Procedure: Conventional autografting (only when indicated) | Burns | 19 | 2021-06-23actual | 2024-07-30 |
| RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 YearsNCT03624192results2021-07-28Time to Complete ClosureRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Study closed in response to COVID-19 and overall program objectives. | Device: RECELL® Autologous Cell Harvesting Device · Other: Telfa™ Clear and Xeroform™ dressings | Skin; Deformity | 3 | 2020-01-13actual | 2024-07-18 |
| Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use CasesNCT02992249observationalWound Healing | — | Completed | — | Burns | 100 | May 2019actual | 2020-08-03 |
| A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot UlcersNCT02799121Complete Wound ClosureOpen-label · Treatment | Phase 4 | Completed | Device: ReGenerCell™ Autologous Cell Harvesting Device | Diabetic Foot Ulcer | 16 | 2019-03-29actual | 2019-06-21 |
| Continued Access to the Recell® Device for Treatment of Acute Burn InjuriesNCT03333941results2021-07-19observationalPercentage of Participants With Wound HealingStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: ReCell® Autologous Cell Harvesting Device | Burns | 76 | 2018-12-19actual | 2024-07-30 |
| CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn InjuriesNCT02994654results2021-05-04Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)Randomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: ReCell | Burns | 12 | Dec 2017actual | 2024-07-30 |
| ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn InjuriesNCT02380612results2021-02-23Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)Randomized · Open-label · Treatment | Not applicable | Completed | Device: ReCell Treatment · Procedure: Skin Graft | Burns | 30 | 2016-01-21actual | 2025-01-07 |
| A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg UlcersNCT01743053Wound healingRandomized · Open-label · Treatment | Phase 4 | Completed | Device: Standard Care plus ReCell · Other: Standard Care | Venous Leg Ulcers | 52 | Oct 2015actual | 2016-06-08 |
| A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn InjuriesNCT01138917results2019-05-13Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)Randomized · Open-label · Treatment | Not applicable | Completed | Device: ReCell and Split-thickness skin graft | Burns | 101 | 2014-08-29actual | 2019-05-13 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19