<< Back to the abstract archive
Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures: A Phase I/II Clinical Trial
Debra A Bourne, MD; Isaac James, MS; Jacqueline Bliley, MS; Sheri Wang, BS; Tara Grahovac, MD; Ryan TM Mitchell, MD; Spencer Brown, PhD; Fabrisia Ambrosio, PhD, MPT; Jonhan Ho, MD; Bernd Lannau, MD; Paul D Kemp, PhD; Jeffrey Gusenoff, MD; J. Peter Rubin, MD
University of Pittsburgh Medical Center
2016-01-25
Presenter: Debra Bourne
Affidavit:
This project represents original work of the resident, Debra Bourne with the co-authors listed. Debra contributed significantly to data acquisition, analysis and interpretation and drafted the abstract.
Director Name: Joseph Losee
Author Category: Resident Plastic Surgery
Presentation Category: Clinical
Abstract Category: General Reconstruction
PURPOSE - Wound contracture creates significant morbidity following burn injuries. Viable human dermal fibroblasts may promote remodeling of scar tissue. ICX-RHY-013 (Intercytex Ltd., United Kingdom) is an investigational medicinal product comprised of viable allogeneic human dermal fibroblasts. The primary objective of this study is to determine safety and tolerability, the secondary objective is to evaluate improvement in burn scars.
METHODS - In phase I, four normal, healthy subjects with stable abdominal surgical scars underwent treatment into designated areas within the scar with no injection, vehicle only, or injections of ICX-RHY-013 in escalating doses up to 5 million cells/cm2 with a repeat dose at 4 weeks. The scar was excised and stained with hemotoxylin/eosin or FISH for the Y chromosome. In phase II, nine patients with stable burn scars were treated with ICX-RHY-013 injections at one of three doses: 2.5 million cells/cm2, 5 million cells/cm2, or 2.5 million cells/cm2 with a repeat dose at 4 weeks. Patients were followed for 12 weeks. Scar scales, quality of life questionnaires, physical therapy evaluations, complications, physical examinations, and photographs were collected.
RESULTS - No major complications were reported. Adverse events included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment. Hemotoxylin/eosin stain demonstrated normal scar cell architecture and FISH analysis revealed no Y chromosome containing cells. The Vancouver scar scale improved by from baseline to week 12 (p=0.016).
CONCLUSIONS - Allogenic Human Dermal Fibroblasts are a safe, feasible and promising treatment for scar contractures.
