Clinical Trial: A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLI™ (ex Vivo Cultured Adult Bone Marr

Brief Summary: This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.

Detailed Summary:
Sponsor: Stempeutics Research Pvt Ltd

Current Primary Outcome:

  • Relief of the rest pain [ Time Frame: 6 months ]
    Rest pain will be measured using rest pain scale (0 to10)
  • Healing of ulcerations or reduction of ulcer area in the target limb [ Time Frame: 6 months ]
    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
  • Relief of the rest pain [ Time Frame: 24 months ]
    Rest pain will be measured using rest pain scale (0 to 10)
  • Healing of ulcerations or reduction of ulcer area in the target limb [ Time Frame: 24 months ]
    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain free walking distance [ Time Frame: 6 and 24 months ]
  • Major amputation free survival [ Time Frame: 6 and 24 months ]
  • Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 and 24 months ]
  • Increase in transcutaneous partial oxygen pressure (TcPO2) [ Time Frame: 6 and 24 months ]
  • Quality of life by King's College VascuQOL questionnaire [ Time Frame: 6 and 24 months ]
  • Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [ Time Frame: 6 and 24 months ]
  • The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). [ Time Frame: 6 and 24 months ]
  • Assessment of clinical laboratory parameters [ Time Frame: 6 and 24 months ]
  • Physical examination findings and assessment of vital signs [ Time Frame: 6 and 24 months ]
  • Assessment of electrocardiogram (ECG) parameters [ Time Frame: 6 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Stempeutics Research Pvt Ltd

Dates:
Date Received: November 27, 2011
Date Started: January 2012
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016