Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

Conditions

Burns

Brief summary

This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.

Kevin N Foster, Joséph Molnár, William L. Hickerson, Jeanne Lee, Brett Hartman et al. (10 authors)

Journal of Burn Care & Research2021-04-011 citations

10.1093/jbcr/irab032.128

96 Treatment of Donor Sites in Large TBSA Burn Injuries with an Autologous Skin Cell Suspension Supports Early Reharvesting

Kevin N Foster, James H. Holmes, William L. Hickerson, Jeffrey W. Shupp, Robert L. Sheridan et al. (14 authors)

Journal of Burn Care & Research2020-03-01

10.1093/jbcr/iraa024.099

104 This is How We Do It: Rehabilitation Following the Use of an Autologous Cell Harvesting Device

Daisuke Nakamura, Elizabeth Richardson, Christopher Craig, Jeffrey W. Williams, J E Carter et al. (7 authors)

Journal of Burn Care & Research2019-03-081 citations

10.1093/jbcr/irz013.105

498 Healing of Donor Sites with an Autologous Skin Cell Suspension for Large TBSA Burn Injuries: A Prospective Evaluation

Kevin N Foster, Karen Richey, Suzanne Osborn, Brooke Burkey, J Carter et al. (16 authors)

Journal of Burn Care & Research2019-03-08

10.1093/jbcr/irz013.391

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* The patient requires treatment of a life-threatening wound requiring grafting. * Patient has inadequate available skin to harvest for conventional skin grafting. * The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition. * In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device. * Patient is hemodynamically stable. * The patient (or legal representative) is able to read and understand instructions and give informed consent.

Exclusion criteria

* The patient has active infection at the proposed ReCell treatment site. * The patient is unable to follow the protocol. * The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.

Design outcomes

Primary

Measure	Time frame	Description
Wound Healing	Wound healing assessed at all study visits	\> 95% epithelialization with a contiguous layer of viable epithelium

Countries

United States

Outcome results