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