PAD: MarrowStim PAD Kit Uses Patient’s Bone Marrow Cells To Improve Critical Critical Limb Ischemia

MedicalResearch.com Interview with:

Michael P. Murphy, MD

Dr. Michael Murphy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores, or gangrene.  Up to 30% of patients with CLI do not qualify for conventional interventions, such as a bypass or angioplasty, putting them at risk for amputation.

The MOBILE trial (MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa in Subjects with Severe Peripheral ArteriaL DiseasE) was designed to assess the safety and efficacy of using autologous concentrated bone marrow aspirate (cBMA), cells derived from the patient’s own bone marrow, to restore blood flow and prevent amputations in patients with CLI.

MOBILE is a Phase 3, double-blind, randomized, placebo-controlled trial that evaluated 152 patients with CLI at 24 centers in the U.S. Patients were randomized to receive cBMA or placebo via injection at 40 sites on the symptomatic leg.  The cBMA was obtained from each patient using the MarrowStim PAD kit.  The placebo group underwent a sham bone marrow aspiration and received needle punctures in the index leg.

The primary efficacy endpoint was amputation-free survival, defined as freedom from all causes of death and/or major amputation, at 52 weeks after treatment. Other endpoints included changes in blood flow in the leg, wound healing, measures of pain and quality of life, and distance walked in 6 minutes. The trial completed in June 2016, and a preliminary analysis found that cBMA demonstrated a meaningful improvement in amputation-free survival and a comparable safety profile to placebo.

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Missing Hand Persists in Brain Decades After Amputation

MedicalResearch.com Interview with:
Sanne Kikkert, DPhil student
FMRIB Centre, University of Oxford
Oxford, United Kingdom

MedicalResearch.com: What is the background for this study?

Response: One of the most mysterious questions about the brain’s ability to adaptively change to new circumstances is: what happens to the brain once a key input is lost (e.g. through amputation)? It has been thought that the hand representation in the brain, located in the primary somatosensory cortex, is maintained by regular sensory input from the hand. Indeed, textbooks teach that any sensory representation in the brain will be ‘overwritten’ if its primary input stops. Following this explanation, people who have undergone hand amputation would show extremely low or no activity related to its original focus in the brain area of the missing hand.

However, we know that amputees often experience phantom sensations from their missing hand, such that when asked to move a phantom finger they can ‘feel’ that movement. We previously showed that we can trace some activity in the missing hand brain area when amputees move their phantom hand. In this study, we were interested in finding how the representation of a missing hand is stored in the brain.
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Diabetic Foot Disease and Amputations Vary By Ethnicity

MedicalResearch.com Interview with:
Tom E. Robinson
School of Population Health
University of Auckland, New Zealand

Medical Research: What is the background for this study? What are the main findings?

Response: Diabetic foot disease affects up to 50% of people with diabetes and lower limb amputation is a serious complication that has a great impact both on patient quality of life and healthcare costs.  Foot complications are however potentially preventable with good diabetes and foot care and early intervention. There is international evidence of unexplained ethnic variations in the incidence of lower limb amputation.  This study found that ethnicity was strongly associated with risk of lower limb amputation. For example, New Zealand Maori people with diabetes have 63% higher rates of lower limb amputations and this increased risk is not altered by controlling for a range of demographic and clinical risk factors.  Asian New Zealander’s have much lower risks of amputation but this may, at least in part, be explained by the ‘healthy migrant effect’. Continue reading