Marrow StimTM PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects with Severe Peripheral Arterial Disease (PAD)
ID Number 13-1875Principal Investigator(s)
Victoria J Teodorescu
Department(s) or Division(s)
This study aims to give an option for limb salvage to patients experiencing critical ischemia (loss of sufficient blood flow) in their lower limbs due to advanced peripheral arterial disease (PAD), and who have no other surgical treatment options. The body tries to compensate for lack of blood flow to an area by forming small new blood vessels called "collaterals" around the diseased area in a process called "angiogenesis". There is mounting clinical evidence that suggests the injection of stem cells into a region can effectively help with new blood vessel formation. The investigational device, called the MarrowStim™ PAD Kit, is used to produce concentrated bone marrow aspirate (cBMA) from a sample of the patient's bone marrow. This cBMA contains stems cells that will be injected into multiple sites around the diseased area with the goal that the stem cells in the cBMA will assist the body in forming new blood vessels that can restore some blood flow in the limb. Subjects will be followed for 1 year after this procedure and will be assessed at follow up visits for their quality of life, ability to walk, experience of complications or adverse events, rest pain, and pulses in the ankle and toe, among other medical evaluations. Study patients and the doctor(s) who see them in follow-up (after the 1st post-op day) will be blinded for 1 year as to whether the patient received the bone marrow injections or a placebo procedure, in which no bone marrow is injected. If after 1 year when the patient is unblinded it is discovered that they received the placebo treatment, if the patient still qualifies for the study, they have the option of getting treatment with the bone marrow injections.
Recruiting Patients: Yes