US-based cell-based regenerative medicine company Cesca Therapeutics has reported positive 40-month follow-up results from the feasibility study of the company’s SurgWerks system to treat late stage, no option critical limb ischemia (CLI).

The SurgWerks system is comprised of the SurgWerks Processing Platform, featuring devices and analytics, and indication-specific SurgWerks Procedure Kits designed to be used in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.

It is a complete sterile single-use procedure kit containing medical disposables and testing reagents which are used to collect, process and produce a therapeutic dose within the surgical scope.

"The 12 months follow-up results of the original study have demonstrated that 12 out of the 17 patients experienced successful limb salvage."

The feasibility study involved 17 patients with late stage CLI treated with all the available surgical options barring a major limb amputation.

They were treated with autologous bone marrow derived from stem cells.

The follow-up was approved to determine the longer-term safety and efficacy related to limb salvage, disease progression, and quality of life improvement.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 12 months follow-up results of the original study have demonstrated that 12 out of the 17 patients experienced successful limb salvage.

After 40 months, positive clinical outcome was noted with an overall reduction in rest pain and an improved quality of life.

Cesca Therapeutics subsidiary Totipotent study director and executive director Dr Venkatesh Ponemone said: "These longer-term, post-study follow-up results not only reinforce our belief that autologous bone marrow derived stem cell therapy using our SurgWerks-CLI system is effective, they also suggest that it is durable.”

Ponemone has added that the company is planning to initiate the Phase III pivotal clinical trial of SurgWerks-CLI procedure.