CLIRST III Trial
About the Trial
The Critical Limb Ischemia Rapid Stemcell Treatment (CLIRST) III trial is a pivotal trial evaluating the safety and efficacy of Cesca’s SurgWerks-CLI platform, which utilizes a patient’s own adult stem cells to stimulate the regeneration of blood vessels, promote wound healing and to save the limb from amputation . Previous clinical trials have demonstrated the regeneration of blood vessels and improved blood circulation in the limb by injection of a patient’s own bone marrow cells. The trial is led by Dr. Richard Powell MD, who is the Section Chief and Professor of Surgery and Radiology at Geisel School of Medicine at Darmouth University and is also a member of Cesca’s Clinical Advisory Board. The trial is expected to enroll over 200 patients at over 40 sites in the USA.
In November, 2015 Cesca received approval for Medicare coverage for the investigational device exemption (“IDE”) CLIRST III study from the Centers for Medicare and Medicaid Services (“CMS”), a federal agency within the United States Department of Health and Human Services. According to the official correspondence from CMS, Cesca’s IDE study was consistent with conditions specified in the IDE regulations and was therefore approved for Medicare coverage. This approval extends coverage across all Medicare administrative regions.
The CLIRST III trial was approved by the US FDA and is expected to begin patient enrollment in late 2016.
The study is designed for patients between the ages of 40 and 85 who have the following conditions , ask your doctor about participation in this clinical trial:
*Foot Ulcer that does not heal
* Leg or foot pain while walking or at rest
*Diagnosis of Critical Limb Ischemia
* Rutherford Stage 5 foot ulcer
*Your doctor has informed you that amputation is your only option for treatment
Patients are disqualified from the study if:
*They are on dialysis * They have uncontrolled Diabetes
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects will be randomized in 3:1 ratio (device treatment: placebo-control). During the procedure, bone marrow will be collected bilaterally from the patient’s iliac crests using the SurgWerks-CLI Kit aspiration trocar under local anesthesia with mild to moderate sedation or general anesthesia, processed through the VXP System to yield a rich bone marrow cell concentrate (“aBMC”). The Treatment Arm will receive the aspirated bone marrow concentrate, which will be intra-muscularly injected at multiple mapped sites/angiosomes into the ischemic index limb using Therapeutic Infusion Needles supplied by the SurgWerks(TM)-CLI procedure kit and standard hypodermic needles. The procedure will be performed in a surgical suite and will take approximately 1.5-2.0 hours to complete. The subjects will be observed for 24 hours following the procedure in the hospital for control as necessary of post-operative pain, bleeding, or infection.
Placebo Arm subjects will undergo an intra-operative point of care aspiration and preparation of bone marrow via the investigational device exactly as the Treatment Arm. However, instead of receiving the dose of bone marrow concentrate, they will receive an intramuscular injection of the patient’s own peripheral blood into the afflicted lower index limb.
At pre-specified follow-up intervals, all subjects in each arm will be evaluated for:
- Major limb amputation-free survival
- Time to Treatment Failure (TTF)
- Wound healing: Quantitative evaluation of wound(s)
- Quality of life assessment (VascuQoL and SF-36)
- Skin Perfusion Pressure (SPP) – Quantitative evaluation of blood flow
- Rest pain assessment
- Brachial Index (ABI
Read more about Critical Limb Ischemia here.