Follow-up Study to Evaluate the Safety of Prochymal for the Treatment of GVHD Patients - Full Text View

Follow-up Study to Evaluate the Safety of Prochymal for the Treatment of GVHD Patients

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	M.D. Anderson Cancer Center Osiris Therapeutics
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00476762

Purpose

Primary Objective:

1. To evaluate the long-term safety of Prochymal™ (human mesenchymal stem cells) at doses of 2x106 and 8x106 hMSCs/kg in subjects treated for acute graft versus host disease (GVHD), Grades II-IV, following allogeneic hematopoietic stem cell transplantation.

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: Prochymal	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	A Long-Term Follow-up Study to Evaluate the Safety of Prochymal (Ex-Vivo Cultured Adult Human Mesenchymal Stem Cells) for the Treatment of Acute Graft Versus Host Disease in Subjects Who Receive Allogeneic Hematopoietic Stem Cell Transplantation

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Evaluate the long-term safety of Prochymal™ (human mesenchymal stem cells). [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Active Comparator Prochymal	Drug: Prochymal Dose 1: 2x10^6 hMSCs/kg; Dose 2: 8x10^6 hMSCs/kg

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be 18 to 70 years of age inclusive.
Patient must have received any treatment with the Investigational Agent in the preceding Prochymal™ study (Protocol 2005-0168).
Patient must have completed their participation in a preceding Prochymal™ study (Protocol 2005-0168).
If female and of child-bearing age, patients must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.
Patient must provide written informed consent and written authorization for disclosure and use of PHI.

Exclusion Criteria:

1) There are no exclusion criteria. Patients must meet above inclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476762

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Osiris Therapeutics

Investigators


Principal Investigator:	Partow Kebriaei, MD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Partow Kebriaei, MD/Assistant Professor )
Study ID Numbers:	2005-0169
First Received:	May 21, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00476762
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Graft Versus Host Disease

Prochymal

Human Mesenchymal Stem Cells

Stem Cell Transplantation

hMSCs

GVHD

Study placed in the following topic categories:

Graft versus host disease

Graft vs Host Disease

Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008