COMPANY

Castle Creek Biosciences

HQ: Exton, PA source · castlecreekbio.com ↗ · Mid-Atlantic

Castle Creek Biosciences, Inc., is a late-stage company developing re-dosable gene therapies. From company website Source · Oct 13, 2026

Keywords: gene therapy Recessive Dystrophic Epidermolysis Bullosa Bilateral Nasolabial Fold Wrinkles Dystrophic Epidermolysis Bullosa Morphea Localized Scleroderma Scleroderma Recessive Epidermolysis Bullosa Dystrophica Restrictive Burn Scars Dysphonia Resulting From Vocal Fold Scarring Age-related Dysphonia Interdental Papillary Insufficiency Acne Scarring of the Face Facial Wrinkles and Creases Restrictive Burn Scars of Joint Area Autologous Human Fibroblasts (azficel-T) FCX-007 (dabocemagene autoficel; see below for FCX-007 description) D-Fi FCX-013 FCX-007 Autologous fibroblasts Azficel-T (autologous fibroblasts) Autologous Human Fibroblasts (Isolagen TherapyTM)

Location: Exton, PA · source · Oct 15, 2026

Profile checked Oct 10, 2026

12Trials (company is sponsor)1NIH grants

Timeline

Mar 27, 2025 Trial start Phase 3: Evaluation of D-Fi for the Treatment of Wounds Due to DEB source ↗
Jun 9, 2020 Trial start Phase 3: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa source ↗
Dec 18, 2019 Trial start Phase 1/Phase 2: A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) source ↗
Jul 1, 2016 Trial start Phase 1/Phase 2: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) source ↗
2014-03 Trial start Phase 2: Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia source ↗
2013-05 Trial start Phase 2: Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars source ↗
2008-02 Trial start Phase 2: Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars source ↗
2007-11 Trial start Phase 2/Phase 3: Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring source ↗
2007-03 Trial start Phase 2: Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases source ↗
2006-11 Trial start Phase 3: Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles source ↗
2006-10 Trial start Phase 3: Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles source ↗
2006-01 Trial start Phase 2: Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency source ↗

Upcoming milestones

2027-09 (ESTIMATED) · Phase 3 · Evaluation of D-Fi for the Treatment of Wounds Due to DEB · NCT06892639

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 12

Record	Title	Phase	Status	Start	Primary completion
NCT04213261	A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa	Phase 3	Active, not recruiting	Jun 9, 2020	Jan 17, 2023 (actual)
NCT06892639	Evaluation of D-Fi for the Treatment of Wounds Due to DEB	Phase 3	Active, not recruiting	Mar 27, 2025	2027-09 (estimated)
NCT03740724	A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)	Phase 1/Phase 2	Terminated	Dec 18, 2019	Sep 23, 2020 (actual)
NCT02810951	A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)	Phase 1/Phase 2	Terminated	Jul 1, 2016	Sep 29, 2020 (actual)
NCT01858753	Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars	Phase 2	Terminated	2013-05	2016-05 (actual)
NCT02120781	Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia	Phase 2	Completed	2014-03	2016-04 (actual)
NCT00655889	Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency	Phase 2	Completed	2006-01	2008-04 (actual)
NCT00642642	Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring	Phase 2/Phase 3	Completed	2007-11	2009-03 (actual)
NCT00655356	Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles	Phase 3	Completed	2006-11	2008-07 (actual)
NCT00649428	Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles	Phase 3	Completed	2006-10	2008-07 (actual)
NCT00654654	Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases	Phase 2	Completed	2007-03	2008-06 (actual)
NCT00620737	Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars	Phase 2	Withdrawn	2008-02	2008-12 (estimated)

NIH awards 1

Annual award amounts. Total $500K.

Jan 11, 2022 NIH award 6R01FD007289-02 FY2021: $500,000 awarded for that fiscal year; activity R01 (OTHER_NIH); PI SPELLMAN, MARY; recipient as written: CASTLE CREEK BIOSCIENCES, LLC, EXTON, PA. A Pivotal Phase 3 Study of FCX-007 source ↗

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