A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers

This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Other: Standard Care; Device: Standard Care plus ReCell

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Hôpital Lapeyronie
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Teaching Hospitals
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals - Addenbrooke's Hospital
  • Cardiff, United Kingdom, CF24 0DE
    • Cardiff University
  • Doncaster, United Kingdom, DN2 5LT
    • Doncaster and Bassetlaw Hospitals
  • Leeds, United Kingdom, LS9 7TF
    • The Leeds Teaching Hospitals - James's University Hospital
  • Manchester, United Kingdom, M23 9LT
    • University Hospital of South Manchester - Wythenshawe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Chronic venous leg ulcer (CEAP Clinical classification of 6)

   1. Confirmed, actively managed venous reflux
   2. No exposed tendon or bone
   3. Ulcer is >4 weeks in duration
   4. Ulcer surface area between 2cm2 and 80cm2
2. ABI ≥ 0.8
3. The patient is 18 years of age or older
4. The patient is willing to complete all follow-up evaluations required by the study protocol
5. The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
6. The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
7. The patient is able to read and understand instructions and give voluntary written informed consent
8. The patient is able and willing to follow the protocol requirements (including compression therapy)
9. Patients enrolling at any site in France must have an affiliation to a social security scheme

Exclusion Criteria:

1. Study treatment area has exposed bone or tendon
2. Poorly controlled diabetes
3. Arterial insufficiency (ABI < 0.8)
4. Pregnant/lactating females (self-reported or tested, per institutional requirements)
5. The patient has an active wound infection requiring antibiotic therapy
6. The patient has had a prior surgical treatment of the ulcer within the past 60 days
7. The patient has a life expectancy of 1-year or less
8. The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
9. The patient is unable to follow the protocol
10. The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
11. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
12. The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
13. The patient is a vulnerable or protected adult.
14. The patient is unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control: Standard Care; The control group will receive standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa™ Clear).	Other: Standard Care
Experimental: ReCell; The ReCell group will receive ReCell in addition to standard care (debridement, cleansing) and Profore® multi-layer compression therapy (replacing the wound contact layer with Telfa Clear).	Device: Standard Care plus ReCell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	The primary objective of the study is to assess the difference in incidence of ulcer closure (investigator assessed as complete epithelialisation without drainage) between the ReCell group and the control group.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wounds characterization/Quality of Life	Wound area; Wound volume; Pain; Recurrence; Health-related Quality of Life	At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks)
Dressing Change	- Dressing change	At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed

Collaborators and Investigators

• Sponsor: Avita Medical
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: CTP003