A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be achieved through regular assessment of adverse events, vital signs, blood work monitoring and laboratory analysis cellular properties of the scar through biopsy.

The secondary objectives of this study are to evaluate improvement in symptoms of scars including reduced pain, discomfort and itching, improvement in mobility and daily function, improvement in appearance and scar texture.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: United States Department of Defense

Criteria

Inclusion Criteria:

1. Subjects who are male or female, military or civilian, age 18 to 65 years of age and able to provide informed consent

2. Subjects who have suffered an injury which has occurred no less than 6 weeks prior to their screening date which has resulted in a stable restrictive scar contracture

1. Stable restrictive scar contracture that has resulted from abdominal surgical incision and does not transverse a joint (Cohort 1 only).

2. Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint (Cohorts 2-5 only)

3. Subjects will have a minimum scar length of 7 cm and a maximum scar area size of 80cm² (Cohort 1 only)

4. Subjects will have a minimum scar area size of 1cm² and a maximum scar area size of 80cm² (Cohort 2-5 only).

5. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits

Exclusion Criteria:

1. Subjects with previous use of cellular therapy (e.g. Isolagen) in the treatment area

2. Subjects with a known history of keloids

3. Subjects with a known history of bleeding disorders

4. Subjects who have facial restrictive scar deficits, not to exclude the neck area.

5. Subjects who have had contracture-release procedures in the treatment area within the previous six months

6. Subjects with a known allergy to any of the constituents of HypoThermosol-FRS

7. Subjects taking immunosuppressive therapy including systemic steroids will be excluded if they have received any dose >7.5 mg of prednisone equivalent/day for more than one week within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study (Intranasal/inhaled steroids are acceptable)

8. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment

9. Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)

10. Subjects with a history of hypersensitivity to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lidocaine, etc)

11. Subjects with planned major surgical intervention during the course of the study.

12. Subjects with known idiopathic or drug-associated coagulopathy

13. Subjects taking medicinal products known to reduce hemostasis (e.g. heparin, Coumadin, etc.) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce hemostasis during the 12 week study period

14. Subjects who have taken any other investigational product within 30 days prior to screening or planned use of any other investigational product during the study period.

15. Subjects who are pregnant, lactating, planning pregnancy and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase

16. Subjects with abnormal blood biochemistry or any other abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures, as determined by the investigator (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).

17. Subjects who have, as determined by the investigator a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (i.e. Type 1 and Type 2 diabetic patients) or any condition within the last 14 days requiring hospitalization or surgical intervention.

18. Subjects with evidence of any past or present clinically significant medical condition that would impair wound healing

19. Subjects with a known hypersensitivity to gentamycin, amphotericin B, Bovine serum or porcine products.

20. Subjects with known alcohol or narcotic drug dependency

21. Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).

22. Subjects receiving an immunosuppressive medication regime including transplant anti-rejection agents.

23. Subjects with an Axis II to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion