Trial record 5 of 220 for:    603

Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT01233960
First received: November 2, 2010
Last updated: June 23, 2014
Last verified: June 2014

November 2, 2010
June 23, 2014
September 2010
July 2017   (final data collection date for primary outcome measure)
Disease remission [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
CDAI at or below 150 and increase in IBDQ
Same as current
Complete list of historical versions of study NCT01233960 on ClinicalTrials.gov Archive Site
  • Disease Improvement [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
    CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
  • Improvement in Quality of Life (IBDQ) [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
    IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
  • Number of Adverse events as a measure of safety [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
  • Infusional toxicity as a measure of safety and tolerability [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
    Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.
Same as current
Not Provided
Not Provided
 
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Drug: adult human mesenchymal stem cells
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Other Names:
  • Prochymal
  • adult human mesenchymal stem cells
  • remestemcel-L
Experimental: Prochymal
Infusions of Prochyaml on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.
Intervention: Drug: adult human mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have qualified for, enrolled in, and provided written ICF and authorization for use and disclosure of PHI for Protocol 603 after the August 3, 2010.
  • Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
  • Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
  • Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
  • Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

Exclusion Criteria:

  • Subject is unwilling or unable to adhere to requirements of Protocol 611.
  • Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
  • Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   New Zealand
 
NCT01233960
CRD 611
No
Mesoblast, Ltd. ( Mesoblast International Sàrl )
Mesoblast International Sàrl
Not Provided
Not Provided
Mesoblast, Ltd.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP