Clinical Trial: MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: MT2014-14 Intrathecal Administration of Mesenchymal Stem Cells (IT-MSC) for the Treatment of Advanced Cerebral Adrenoleukodystrophy (cALD)
Brief Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).
Detailed Summary: This is a single-institution dose escalation study to determine the maximum tolerated dose (MTD) of intrathecally administered allogeneic, 3rd party mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).
Sponsor: Masonic Cancer Center, University of Minnesota
Current Primary Outcome: Maximum Tolerated Dose [ Time Frame: Day 28 post intrathecal injection of MSC ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Radiographic Response [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Masonic Cancer Center, University of Minnesota
Dates:
Date Received: March 27, 2015
Date Started: June 2015
Date Completion: July 2022
Last Updated: February 17, 2017
Last Verified: February 2017