August 3, 2016 10:41am
From 40-Month Follow-Up of patients enrolled in of late stage, “no option” critical limb ischemia (CLI) feasibility trial
The feasibility study was conducted in 2011 at Fortis Escorts Heart Institute in New Delhi, India, where seventeen patients with late stage CLI, all of whom had exhausted available surgical options short of a major limb amputation, were treated with autologous bone marrow derived stem cells.
The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longer-term safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.
Results from the original study reported successful limb salvage for twelve of the seventeen patients after twelve months.
- In the 40-month follow-up, three of the 12 patients that were amputation-free at 12 months could not be contacted, but the remaining nine were clinically assessed.
- The results reported favorable clinical outcomes, including a significant overall reduction in rest pain and improvements in quality of life.
- All nine patients still had their limbs and exhibited no sign of disease progression, though two of the nine had in the interim undergone additional SurgWerks treatments to relieve mild to moderate rest pain.
- There were no adverse or serious adverse events reported at the 40 month follow-up, and there were no safety concerns attributed to the treatment procedure.
KOOL is UP +$1.38 or +31.01% to $5.83 on huge 4.761 M share volume <3 month average = 545.4 K>. The day’s range is $5.83 to $7.39 and slipping …
