Stem Cell Treatment of Critical Limb Ischemia
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 that won't heal in the legs and feet. Left untreated, the complications of CLI will result in amputation of the affected limb.
The XCell-Center Critical Limb Ischemia Treatment
The XCell-Center's CLI 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 in Germany for 4 or 5 nights.
Bone Marrow Collection
On the
first day, 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).
Laboratory Processing
The next
day, 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.
Stem Cell Implantation
On the third day, the stem cells are implanted back into the patient by angiography to the affected vessel(s) under local anesthesia. If neccessary, treatment might include dilatation and/or stenting of narrowed and/or blocked vessels in addition to the stem cell implantation.
Angiography - 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.
Treatment Results
The interim analysis of vascular surgery protocol "Autologous Mesenchymal cells for the treatment of patients with critical limb ischemia" is now available and so far, the results are promising.
A total of 6 patients were treated from September 30th, 2009 through November 12th, 2009. 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.
Cost
The price of the Critical Limb Ischemia angiography treatment is 9,925 Euros.
Evaluation Process
To begin the 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 within 3 business days. 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.
If you will be in Germany, you may also schedule an in-person consultation/evaluation with an XCell-Center physician. You may also request a "fast-track" evaluation and treatment schedule.
