Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD



Status:No longer available
Conditions:Orthopedic, Hematology
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:Any - 17
Updated:7/14/2018

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Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

This protocol allows for the treatment of pediatric patients, male and female, between the
ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D
acute GVHD.

For the treatment of pediatric patients who have failed to respond to steroid treatment for
acute graft-versus-host disease (GVHD). Failing steroid treatment for acute GVHD is defined
as any Grade B-D (IBMTR grading) of acute GVHD that is not improving after at least 3 days of
methylprednisolone (≥ 1 mg/kg/day) or equivalent.

Patients will be treated with Prochymal twice per week at a dose of 2 x 10^6 hMSC/kg (actual
body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days
apart.

Inclusion Criteria:

- Patients must be 2 months to 17 years of age, inclusive

- Patients who have failed to respond to steroid treatment for Grades B-D acute GVHD

- Patient must not have a known allergy to bovine or porcine products

- Patient must not have received a transplant for a solid tumor disease.

- Patient must not have evidence of a pulmonary infiltrate or diffuse alveolar
hemorrhage and is likely to require more than 2L of oxygen via face mask or an
estimated FiO2 of 28% via other delivery methods in order to sustain an O2 saturation
of 92% during the next 3 days.
We found this trial at
25
sites
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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San Antonio, TX
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Calgary, Alberta
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Calgary,
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Charlotte, North Carolina 28204
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Charlotte, NC
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Chicago, Illinois 60614
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Chicago, IL
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Indianapolis, Indiana 46202
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Indianapolis, IN
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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New Orleans, Louisiana 70118
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New York, New York 10032
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Portland, OR
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Richmond, Virginia 23298
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Richmond, VA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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1635 Divisadero Street
San Francisco, California 94143
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Washington, District of Columbia 20010
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Washington,
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