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Genetic Therapy

FCX-013 for Linear Scleroderma

Phase 1 & 2
Waitlist Available
Research Sponsored by Castle Creek Biosciences, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a treatment for severe localized scleroderma involving injections of modified cells and a pill. The cells produce a protein to break down excess collagen, and the pill helps control this process.

Eligible Conditions
  • Linear Scleroderma
  • Morphea
  • Scleroderma
  • Localized Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study initiation through study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and study initiation through study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the Safety of FCX-013 Plus Veledimex
Secondary study objectives
Evaluate the Antifibrotic Effects of FCX-013 Plus Veledimex

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FCX-013 + veledimexExperimental Treatment2 Interventions
Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
veledimex
2015
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Castle Creek Biosciences, LLC.Lead Sponsor
10 Previous Clinical Trials
644 Total Patients Enrolled
Mary C Spellman, MDStudy DirectorCastle Creek Biosciences, LLC.
Clinical Trial DirectorStudy DirectorCastle Creek Biosciences, LLC.
3 Previous Clinical Trials
94 Total Patients Enrolled
~0 spots leftby Nov 2025
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