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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Graft-Versus-Host Disease

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Trial Information

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


This is a treatment protocol to provide patients who have failed steroid treatment for acute
GVHD expanded access of Prochymal. It is anticipated that a maximum of 10 patients per month
for a total of 120 patients per year will be treated according to this protocol.

Patients will be treated with Prochymal twice per week at a dose of 2 x 106 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 18 years to 70 years of age, inclusive.

- Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting
with diarrhea or abnormal liver function tests caused by infection.

- Patients must have failed to respond to steroid treatment (methylprednisolone
[≥1mg/kg/day] or equivalent) for Grades C-D acute GVHD.

- Prochymal must be administered not longer than 14 days after the initiation of
systemic steroid therapy for acute GVHD.

- Prochymal must be administered either before or at the same time any additional GVHD
therapy is administered

- Patients must have an adequate renal function as defined by Cockroft-Gault
equation:Calculated creatinine clearance (CrCl) > 30mL/min

- Patients who are women of childbearing potential, must be non-pregnant, not
breast-feeding, and use adequate contraception. Male patients must use adequate
contraception.

Exclusion Criteria:

- Patient has stage 3 or 4 liver GVHD, bilirubin >6 mg/dl.

- Patient has stage 4 GI-GVHD.

- Patient has any underlying or current medical condition that would interfere with the
evaluation of the patient including uncontrolled infection, sepsis, organ failure,
etc or any medical condition that has a high probability of causing death in less
than 30 days.

- Patient may not receive any other investigational agent (not approved by the FDA for
any indication) concurrently for the duration of the protocol.

- Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and
must not be likely to require more than 2L of oxygen via face mask or an estimated
FiO2of 28% via other delivery methods in order to sustain an O2 saturation of 92%
during the next 3 days.

- Patient has a known allergy to bovine or porcine products

- Patient has a medical history of a solid tumor disease.

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

276

NCT ID:

NCT00826046

Start Date:

Completion Date:

Related Keywords:

  • Graft-Versus-Host Disease
  • GVHD
  • Prochymal
  • Graft vs Host Disease
  • Graft vs Host Disease

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Indiana BMTBeech Grove, Indiana  46107