Critical Limb Ischemia
	Peripheral (Occlusive) Artery Disease
	Diabetic Foot – Threatened Amputation
	Diabetic Non-healing Ulcers

Critical limb ischemia is a severe obstruction of the arteries, which seriously decreases blood flow to the hands, feet or legs. [1] It is the end-stage of lower extremity peripheral artery disease (PAD/POAD) and results in pain (even at rest), ulcers that do not heal and a significant risk of gangrene leading to limb loss. [2]

Despite advances in surgical treatment modalities, there are still between 160,000-180,000 leg amputations in the United States annually due to CLI. The occurrence of CLI increases significantly in patients with diabetes and it is estimated that worldwide, an amputation is performed every 30 seconds on a person suffering from diabetes. Within three to five years of a CLI sufferer’s first amputation, roughly 30 – 40 percent of amputees will undergo a second limb amputation. Mortality and morbidity rates after an amputation remain high. [3]  

Autologous Mononuclear Stem Cell Therapy for CLI, PAD, Diabetic Foot and Diabetic Ulcer

Autologous bone marrow mononuclear cells contain hematopoietic stem cells, mesenchymal stem cells and endothelial progenitor cells [4] (vascular progenitor cells), which are needed for the growth of new blood vessels and which improve the blood supply to the diseased extremities in CLI, PAD and diabetic foot sufferers. Studies have proven that bone marrow cell transplantation has been shown to induce angiogenesis (the growth of new blood vessels from pre-existing vessels) and thus improve ischemic artery disease. In no-option patients with end-stage critical limb ischemia due to peripheral artery disease, bone marrow cell transplantation is a safe procedure that can improve leg perfusion sufficiently to reduce major amputations and permit durable limb salvage. [5] 

Further studies have proven that autologous bone marrow aspiration concentrate administration for CLI patients with diabetic foot is a safe and promising technique for end-stage limb salvage. Most published studies have reported success rates of 66 – 70 percent limb salvage by stem cell therapy. In one study, mononuclear stem cell therapy was able to save 80% of legs with significant improvement in toe pressure, tissue perfusion and better metabolism of critically ill legs. [6] 

Preliminary evidence has also established the safety, feasibility and effectiveness of autologous bone marrow stem cell therapy on several important endpoints. Clinical benefits were reported from trials including improvement of ankle-brachial index (ABI), transcutaneous partial pressure of oxygen (TcPO2), reduction of pain, and decreased need for amputation. [7] 

Autologous Stem Cell Therapy for CLI, PAD, Diabetic Foot and Diabetic Ulcer at the Apollo Bramwell Hospital

Upon registration, the doctor performing the SCT will give you a physical examination and your medical records will be reviewed once again. Your doctor may order additional testing, such as blood tests or radiological testing. The following day one of the Apollo Bramwell Hospital specialists will harvest bone marrow from your hip. This procedure normally takes 30-60 minutes. You are then given sedative medications and local anesthesia is administered to the area of the skin where a small incision is made to aspirate the bone marrow. A special bone marrow needle will be used to collect 240 ml of bone marrow, which will be processed in a special machine to separate the mononucleated cells from the rest of the bone marrow. 

The specialist doctor then will administer your concentrated mononucleated cells back to you. The cells are administered intramuscularly along the territories of the diseased blood vessels. The medical team will monitor you for 2 to 24 hours after the administration of the therapy. Generally, a stay of two days or longer is required in the hospital, depending on the condition of the individual patient. 

Medical Records Required for Patient Evaluation

The medical records required by the Apollo Bramwell Hospital to determine your eligibility for stem cell therapy for critical limb ischemia, peripheral (occlusive) artery disease, diabetic foot or diabetic non-healing ulcer are: 

• Reports of consultations with the specialist pertaining to the current illness;
• The list of medications that the patient is currently on (Generic and Brand names of prescribed drugs);
• Lab reports (biochemical and blood investigations);
• Imaging reports – Eg. Doppler Studies / Angiograms / X-Rays / CT or MRI;
• Reports of previous hospitalizations if any (pertaining to PAD/CLI);
• Risk evaluation reports like ECG (aka EKG), Cardiac Echo;
• Details of any co-morbidities (like Hypertension, Diabetes, Bleeding disorders, Hepatitis, HIV etc).

Please note that the medical records supplied need to be no older than three months. 

About Stem Cell Therapy

Stem cell therapy for critical limb ischemia, peripheral (occlusive) artery disease, diabetic foot and diabetic non-healing ulcer should be considered for patients who have exhausted all traditional medicinal and surgical interventions. The end-stage of these diseases is ultimately limb amputation. Autologous mononuclear stem cell therapy has provided evidence-based medicine to prove safety and efficacy in treating these diseases. There is however, no guarantee of treatment efficacy and treatment results will vary on a patient by patient basis. Some patients may experience no improvement in their condition after receiving stem cell therapy whilst other patients may experience significant improvements.