Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/28/2019 |
| Start Date: | May 2014 |
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.
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.
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.
We found this trial at
22
sites
Phoenix, Arizona 85008
Principal Investigator: Kevin Foster, MD, MBA,FACS
Phone: 602-344-5141
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jeremy Goverman, MD
Phone: 617-726-3712
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Philadelphia, Pennsylvania 19134
Principal Investigator: Wellington Davis III, MD
Phone: 215-427-4619
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22 Bramhall St
Portland, Maine 04102
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Elizabeth Turner, MD, CM, MSc
Phone: 617-775-4469
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Juvonda S Hodge, MD
Phone: 904-557-8599
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Augusta, Georgia 30909
Principal Investigator: Robert F Mullins, MD
Phone: 706-364-2966
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Baton Rouge, Louisiana 70809
Principal Investigator: Tracee C Short, MD
Phone: 225-237-1673
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51 Blossom Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Principal Investigator: Robert Sheridan, MD
Phone: 617-371-4808
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Columbia, Missouri 65203
Principal Investigator: Jeffrey S Litt, DO, FACS
Phone: 573-882-4387
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3698 Chambers Road
Fort Sam Houston, Texas 78234
Fort Sam Houston, Texas 78234
Principal Investigator: Julie A Rizzo, MD
Phone: 210-916-9689
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Indianapolis, Indiana 46202
Principal Investigator: Rajiv Sood, MD FACS
Phone: 317-410-4484
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Jackson, Mississippi 39204
Principal Investigator: Jeffrey T Gibbs, MD
Phone: 706-651-6661
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2401 Gillham Road
Kansas City, Missouri 64108
Kansas City, Missouri 64108
Principal Investigator: Pablo Aguayo, MD
Phone: 816-983-6885
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Memphis, Tennessee 38163
Principal Investigator: William L. Hickerson, MD, FACS
Phone: 901-448-2714
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Mobile, Alabama 36688
Principal Investigator: Sidney B. Brevard, MD,MPH,FACS
Phone: 251-471-7988
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New Orleans, Louisiana 70112
Principal Investigator: Jeffrey Carter, MD
Phone: 504-702-3141
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San Diego, California
Principal Investigator: Jeanne Lee, MD, FACS
Phone: 619-543-7665
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Springfield, Missouri 65804
Principal Investigator: Brian Draper, DO
Phone: 417-820-2974
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Washington, District of Columbia
Principal Investigator: Jeffrey W. Shupp, M.D.
Phone: 202-877-6181
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Joseph Molnar, MD, PhD
Phone: 336-716-6709
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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