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Critical Limb Ischemia

Stem Cell Treatment for Critical Limb Ischemia

Critical limb ischemia (CLI) is a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral arterial disease, or PAD, but less common than claudication. PAD is caused by atherosclerosis, the hardening and narrowing of the arteries over time due to the buildup of fatty deposits called plaque.

CLI is a chronic condition that results in severe pain in the feet or toes, even while resting. Complications of poor circulation can include sores and wounds which will not heal in the legs and feet. Left untreated, the complications of CLI will result in amputation of the affected limb.

The Cells4health Critical Limb Ischemia Treatment

The critical limb ischemia stem cell treatment differs from standard methods because it is a drug-free alternative focused on restoring blood flow throughout the affected limbs.

The entire procedure requires patients to stay for 4 or 5 nights.


Step 1 – Bone Marrow Collection

Bone marrow is collected from the patient’s iliac crest (hip bone) using thin-needle mini-puncture under local anesthesia. Although some pain is felt when the needle is inserted, most patients do not find the bone marrow collection procedure particularly painful. The entire procedure normally takes about 30 minutes.

Once the bone marrow collection is complete, patients may return to their hotel and go about normal activities.

More detailed information on the bone marrow collection procedure is available in the Bone Marrow Informed Consent document (PDF file).


Step 2 – Laboratory Processing

The stem cells are processed from the bone marrow in a state-of-the-art, government approved (cGMP) laboratory. In the lab, both the quantity and quality of the stem cells are measured. These cells have the potential to transform into multiple types of cells and are capable of regenerating or repairing damaged tissue.


Step 3 – Stem Cell Implantation

The stem cells are implanted back into the patient by angiography to the affected vessel(s) under local anesthesia.  If necessary, treatment might include dilatation and/or stenting of narrowed and/or blocked vessels in addition to the stem cell implantation.



A special catheter (thin hollow wire) is inserted into the femoral artery and then guided forward under x-ray scanning until it reaches the targeted areas where the stem cells are then injected. The angiography procedure takes about 90 minutes. Afterwards, the patient will spend 2 or 3 hours in the recovery room to ensure that the entry site is not bleeding.


Critical Limb Ischemia Stem Cell Treatment Results

The interim analysis of vascular surgery protocol from the University of Crete, Greece “Autologous Mesenchymal cells for the treatment of patients with critical limb ischemia” is now available and so far, the results are very promising.

A total of 6 patients were treated. Each of these patients was recommended for limb amputation.

The average patient age was 70 years old.  Half of the patients treated underwent a previous amputation.  Two-thirds suffered from diabetes and only one was not hypertensive.  One-third of patients suffered from hyperlipidemia and/or superficial femoral artery stenosis.

4 out 6 patients improved after treatment and did not require amputation.  Of the two remaining patients, one underwent amputation and the other, so far, has not yet consented to it despite its recommendation by the treating physician.

Ankle-brachial pressure index (ABPI) increased by an average of 30% in the improved patients.   AMPI measures the ratio of blood pressure in the lower legs to blood pressure in the arms.  Lower values indicate more severe vascular disease in the legs.  On average, patients were categorized with severe arterial disease by ABPI before treatment.  After treatment, patients improved to the moderate arterial disease category.

Patients were able to walk 70% further after treatment and they reported that limb pain decreased by an average of 20%.

Both patients who did not improve suffered from superficial femoral artery stenosis.


Treatment Evaluation Process

To begin the stem cell treatment evaluation process, you must complete an online medical history form. Once you’ve completed the online medical history and submitted it, a patient relations consultant will contact you. He or she will assist you with the rest of the evaluation process. Upon treatment approval, your consultant will also assist you with treatment scheduling and trip preparation.

Download Treatment Contract

Start the online Medical Treatment Evaluation

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