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Completed

NCT Number: NCT01233960

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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About this study

Participants 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 participants 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
  • Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
  • Participant 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.
  • Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
  • Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

Exclusion criteria

  • Participant is unwilling or unable to adhere to requirements of Protocol 611.
  • Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
  • Participant 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.

Treatment and study plan

Prochymal®

Drug

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: Adult human mesenchymal stem cells, Remestemcel-L

Primary outcomes

  1. Disease remission

    Time frame: 180 Days after first infusion in Protocol 603

    Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ

Secondary outcomes

  1. Disease Improvement

    Time frame: 180 Days after first infusion in Protocol 603

    CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.

  2. Improvement in Quality of Life (IBDQ)

    Time frame: 180 Days after first infusion in Protocol 603

    IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.

  3. Number of Adverse events as a measure of safety

    Time frame: 180 Days after first infusion in Protocol 603

  4. Infusional toxicity as a measure of safety and tolerability

    Time frame: 180 Days after first infusion in Protocol 603

    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.

Sponsors and collaborators

Lead sponsor

Mesoblast, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 3, 2010
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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