Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
- Conditions
- Critical Limb Ischemia (CLI)
- Registration Number
- NCT02538978
- Lead Sponsor
- Cesca Therapeutics, Inc.
- Brief Summary
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).
- Detailed Description
Device arm subjects will receive an intra-operative point of care aspiration, preparation and intramuscular injection of autologous bone marrow cell concentrate (aBMC) into the afflicted lower index limb.
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 device to yield a rich cell and plasma concentrate ("aBMC"). Additionally, 10 mL of autologous peripheral blood will be aspirated for the placebo preparation.
The Treatment Arm will receive the aBMC, which will be intramuscularly injected at multiple mapped sites/angiosomes into the ischemic index limb using the SurgWerks-CLI Kit supplied Therapeutic Infusion Needles 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 for observation and control as necessary of post-operative pain, bleeding, and 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 dosing with the aBMC device output, they will receive an intramuscular injection of diluted autologous 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Major Limb Amputation Free Survival 12 months The measure of survival without a major (above the ankle) amputation within 12 months from the procedure and between group analyses at 12 months.
- Secondary Outcome Measures
Name Time Method Wound healing (photographic method of measuring area, depth, perimeter and volume of wounds) 1, 3, 6 and 12 months Quantitative evaluation of wound volume in continuous metric data (cu.cm.)
Quality of Life Assessment (a PAD-specific health-related quality of life instrument) 1, 3, 6, and 12 months VascuQoL Questionnaire (using subjective, ordinal data regarding walking improvement on a scale of 1-7, where 1="Not at all", and 7= "a very great deal").
Major amputation 12 months Above the ankle amputation
Doubling of wound size 12 months Proportion of wounds that have doubled in size (area)
Skin Perfusion Pressure (SPP) 1, 3, 6 and 12 months Limb pressure measurement as a proxy for tissue perfusion
All-Cause Mortality 12 months Death from any cause
New full thickness lesion 12 months New full thickness lesion (\>1 cm2) on the index limb.