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0 Diseases |  |
2 Trials |
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2 Trials |  |
46 News |  |
- Exploring the Financial Burden Associated with the Management of Dystrophic Epidermolysis Bullosa (DEB): A Systematic Literature Review (SLR) with Database Review of Future Disease-Modifying Therapies (DMTs) () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_1579;
Previously, as there were no DMT options for patients with DEB treatment was symptomatic only. Future innovative DMTs should aim to prevent skin wounds, thereby decreasing the need for hospitalization and outpatient visits.
- FCX-007 / Precigen, Paragon Biosci
Trial completion date, Trial termination: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Feb 8, 2023
P1/2, N=6, Terminated, Sponsor: Castle Creek Biosciences, LLC.
Future innovative DMTs should aim to prevent skin wounds, thereby decreasing the need for hospitalization and outpatient visits. Trial completion date: Dec 2033 --> Apr 2022 | Active, not recruiting --> Terminated; Subjects were all in Long-Term Follow Up and were transferred to the ongoing EB-002 study
- FCX-007 / Precigen, Paragon Biosci
A Randomized Trial to Determine the Efficacy and Safety of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa () - Aug 11, 2022 - Abstract #EADV2022EADV_3197;
- ||||| FCX-007 / Precigen, Paragon Biosci
Enrollment closed, Enrollment change: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Aug 11, 2022
P3, N=6, Active, not recruiting, Sponsor: Castle Creek Biosciences, LLC.
Trial completion date: Dec 2033 --> Apr 2022 | Active, not recruiting --> Terminated; Subjects were all in Long-Term Follow Up and were transferred to the ongoing EB-002 study Recruiting --> Active, not recruiting | N=24 --> 6
- FCX-007 / Precigen, Paragon Biosci
Castle Creek Biosciences, Inc. (Theater 3) - Jun 4, 2022 - Abstract #BIO2022BIO_311;
Castle Creek’s most advanced product candidate, dabocemagene autoficel (FCX-007, D-Fi), an ex vivo, autologous gene therapy, is currently being evaluated in a Phase 3 clinical trial for the localized treatment of chronic wounds due to recessive dystrophic epidermolysis bullosa (RDEB)...Castle Creek Biosciences, Inc. is a portfolio company of Paragon Biosciences, LLC.
- FCX-007 / Precigen, Paragon Biosci
The Treatment of Wounds Associated with Recessive Dystrophic Epidermolysis Bullosa with Local Injections of Gene-Corrected, Collagen VII-Expressing Autologous Human Dermal Fibroblasts (Poster Board Number: Tu-305; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_886;
Local injection of COL7- expressing autologous human dermal fibroblasts (D-Fi, also known as FCX-007) led to wound healing in patients with RDEB...The local injection of gene-corrected autologous fibroblasts to the wounds of RDEB appears to be generally safe, and complete wound healing is typically exhibited. The durability of wound healing needs to be evaluated over a longer period.
- FCX-007 / Precigen, Paragon Biosci
A Randomized Trial to Determine the Efficacy and Safety of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa -DEFI-RDEB (Poster Board Number: Tu-309; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_872;
Safety assessments include adverse events (including the presence of neoplasms), replication-competent lentivirus (RCL), COL7 antibody and clinical laboratory testing. Subjects who have received at least one treatment injection will continue in the long-term safety follow-up period through 15 years.
- | FCX-007 / Precigen, Paragon Biosci
Trial completion date, Trial primary completion date: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Dec 14, 2021
P3, N=24, Recruiting, Sponsor: Castle Creek Biosciences, LLC.
Subjects who have received at least one treatment injection will continue in the long-term safety follow-up period through 15 years. Trial completion date: Jul 2036 --> Jul 2037 | Trial primary completion date: Apr 2022 --> Apr 2023
- FCX-007 / Precigen, Paragon Biosci
Trial primary completion date: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Sep 16, 2021
P1/2, N=6, Active, not recruiting, Sponsor: Castle Creek Biosciences, LLC.
Trial completion date: Jul 2036 --> Jul 2037 | Trial primary completion date: Apr 2022 --> Apr 2023 Trial primary completion date: May 2020 --> Sep 2020
- FCX-007 / Precigen, Paragon Biosci
[VIRTUAL] "A Phase 3 Randomized Trial to Determine the Safety and Efficacy of FCX-007 for the Treatment of Wounds Associated with Recessive Dystrophic Epidermolysis Bullosa () - May 29, 2021 - Abstract #SBS2021SBS_159;
The safety and efficacy of local injection of autologous gene-corrected, COL7-expressing fibroblasts for the treatment of wounds associated with RDEB will be evaluated in this late-phase clinical study. Authors are employees of Castle Creek Biosciences
- | FCX-007 / Precigen, Paragon Biosci
Trial completion date: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Oct 21, 2020
P3, N=24, Recruiting, Sponsor: Fibrocell Technologies, Inc.
Authors are employees of Castle Creek Biosciences Trial completion date: Nov 2035 --> Jul 2036
- ||| FCX-007 / Precigen, Paragon Biosci
Enrollment change: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Aug 8, 2020
P1/2, N=6, Active, not recruiting, Sponsor: Fibrocell Technologies, Inc.
Trial completion date: Nov 2035 --> Jul 2036 N=12 --> 6
- | FCX-007 / Precigen, Paragon Biosci
Trial completion date, Trial primary completion date: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Aug 7, 2020
P3, N=24, Recruiting, Sponsor: Fibrocell Technologies, Inc.
N=12 --> 6 Trial completion date: Mar 2021 --> Nov 2035 | Trial primary completion date: Dec 2020 --> Apr 2022
- || FCX-007 / Precigen, Paragon Biosci
Enrollment open: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Mar 31, 2020
P3, N=20, Recruiting, Sponsor: Fibrocell Technologies, Inc.
Trial completion date: Mar 2021 --> Nov 2035 | Trial primary completion date: Dec 2020 --> Apr 2022 Not yet recruiting --> Recruiting
- |||| FCX-007 / Precigen, Paragon Biosci
New P3 trial: DEFI-RDEB: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - Dec 29, 2019
P3, N=20, Not yet recruiting, Sponsor: Fibrocell Technologies, Inc.
- | FCX-007 / Precigen, Paragon Biosci
Enrollment closed: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Dec 4, 2019
P1/2, N=12, Active, not recruiting, Sponsor: Fibrocell Technologies, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || FCX-007 / Fibrocell Science, Intrexon
Pres & CEO @JohnMaslowski5 to discuss @Fibrocell #genetherapy candidate FCX-007 for RDEB at #BIO2019 on June 4 at 1:00 pm ET. Details https://t.co/wlNjCLVTcS (Twitter) - May 30, 2019
- | FCX-007 / Precigen, Paragon Biosci
Trial primary completion date: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - May 22, 2019
P1/2, N=12, Recruiting, Sponsor: Fibrocell Technologies, Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2018 --> Apr 2020
- | FCX-007 / Fibrocell Science, Intrexon
$FCSC Announces Collaboration with Castle Creek Pharmaceuticals to Develop and Commercialize FCX-007 Gene Therapy. $30M Upfront (Twitter) - Apr 15, 2019
- | FCX-007 / Precigen, Paragon Biosci
Trial completion date, Trial primary completion date: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Aug 3, 2018
P1/2, N=12, Recruiting, Sponsor: Fibrocell Technologies, Inc.
Trial primary completion date: Dec 2018 --> Apr 2020 Trial completion date: Aug 2033 --> Dec 2033 | Trial primary completion date: Aug 2018 --> Dec 2018
- | FCX-007 / Precigen, Paragon Biosci
New P1/2 trial: A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) (clinicaltrials.gov) - Jun 23, 2016
P1/2, N=12, Recruiting, Sponsor: Fibrocell Technologies, Inc.