|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 25, 2005 | ||||
| Last Updated Date | September 3, 2009 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
Response (defined as resolution or reduction of 2 grades) of GI GVHD by Day 42 | ||||
| Change History | Complete list of historical versions of study NCT00136903 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
•Improvement of GVHD by Day 28 in one or more organs involved with GVHD symptoms at day 1 • Time to best response of GVHD • Time to improvement of GVHD in one or more organs [ Time Frame: 28 Days ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute GVHD. | ||||
| Official Title ICMJE | A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of aGVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation | ||||
| Brief Summary | To establish the safety and efficacy of two dose levels of Ex-vivo Cultured Adult HumanMesenchymal Stem Cells (Prochymal) in subjects experiencing acute GVHD, Grades II-IV,post HSC transplant. |
||||
| Detailed Description | Protocol 260 - Subjects will be randomized with equal probability to the treatment arms (2 million cells/kg of Prochymal or 8 million cells/kg of Prochymal) using a stratified block design. The stratification factor is acute GVHD grade. For the purpose of stratification, the GVHD grades are II and III-IV. Treatment with investigational agent was administered on study Days 1 and 4. Patients were followed for safety and efficacy until Day 28 after initiation of treatment with the investigational agent, or until withdrawal or death, whichever occurred first. Protocol 261 - Subjects were evaluated for safety until 2 years from Day 1 of the preceding Prochymal® Protocol No. 260 until withdrawal or death. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Dose Comparison Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Graft vs Host Disease | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 33 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Protocol 260 Inclusion Criteria:
Protocol 260 Exclusion Criteria:
Protocol 261 Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00136903 | ||||
| Responsible Party | Rod Monroy, Ph.D./Sr. Director, Osiris Therapeutic's Inc. | ||||
| Study ID Numbers ICMJE | 260-261 | ||||
| Study Sponsor ICMJE | Osiris Therapeutics | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Osiris Therapeutics | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||