Critical Limb Ischemia

Critical limb ischemia, also called limb threat, is characterized by severe pain in the legs and feet at rest, and sores on the feet or legs that do not heal.Critical limb ischemia is a serious form of peripheral artery disease, with a 12% rate of amputation within 1 year of diagnosis, and a 50% mortality rate at 5 years of diagnosis2.

Symptoms of critical limb ischemia include:

  • Pain or numbness in the feet or legs
  • Sores, infections or ulcers that do not heal
  • Shiny, smooth, dry skin of the legs or feet
  • Absent or reduced pulse in the legs or feet
  • Gangrene of the legs or feet
  • Thick toenails

The Stem Cells Transplant Institute in Costa Rica, uses adult mesenchymal stem cells for the treatment of critical limb ischemia.

What is critical limb ischemia?

Critical limb ischemia is the most severe form of peripheral artery disease.

Peripheral arterial disease occurs when atherosclerosis, the buildup of plaque, causes a narrowing, or blocking of the blood vessels in the peripheral arteries.

Plaque is caused by the presence of cholesterol, calcium, fat and other substances in the blood.

When plaque builds up in the arteries, they harden and weaken, and can no longer send enough blood flow to the extremities, usually the legs.

Critical limb ischemia is associated with a high risk of amputation, myocardial infarction, and death, with mortality rates of 20% within 6 months of initial diagnosis and 50% at 5-years2.

Risk factors for peripheral artery disease and critical limb ischemia include:

  • Smoking
  • Diabetes
  • Obesity
  • High blood pressure
  • High cholesterol
  • Age
  • Family history of peripheral artery disease, cardiovascular disease or stroke
  • High homocysteine levels

The standard treatment for critical limb ischemia is surgical or endovascular revascularization.  Up to 30% of patients do not qualify for treatment because of risks associated with treatment, meaning prognosis for these patients is poor.3  

Critical limb ischemia is associated with a poor quality of life and high treatment costs. Stem cell therapy at the Stem Cells Transplant Institute may be a good alternative for patients seeking a safe, non-surgical treatment for critical limb ischemia.

How can stem cell therapy improve the symptoms of critical limb ischemia?

Stem cell transplantation uses healthy cells to promote the repair of damaged cells and regeneration of healthy and functional cells.

The therapeutic effect of stem cell transplantation in patients with critical limb ischemia may be due to the paracrine effect.

The paracrine effect theory is, transplanted stem cells repair damaged tissue by releasing factors that promote regeneration of healthy stem cells, reduce inflammation, promote the growth of new blood vessels, inhibit cell death, and reduce hypertrophy.

Animal and human trials have shown stem cell transplantation to be safe and effective in patients with critical limb ischemia.

What are scientists researching?

Research has shown stem cell therapy, in critical limb ischemia, resulted in:3,4

  • Improved limb function
  • Amputation free survival
  • Reduce muscle atrophy
  • Reduce the thickening or scarring of connective tissue
  • Improvement in pain and cold sensation
  • Growth of new collateral vessels
  • Improved ankle-brachial index
  • Improved blood flow
  • Increase in walking distance
  • Increase in ulcer healing
  • Improved quality of life measures

Stem cell therapy cannot help all patients with critical limb ischemia, but for many patients, stem cell therapy, combined with lifestyle modification, may be a safe, effective, non-surgical treatment alternative.

Lifestyle changes that can help improve cardiovascular disease include:1,2

  • Quit smoking
  • Following a healthy diet low in salt and saturated fat
  • Maintain a healthy weight
  • Daily exercise
  • Control high blood pressure
  • Control diabetes
  • Control high cholesterol
  • Practice good hygiene

What is the treatment protocol for critical limb ischemia at the Stem Cells Transplant Institute?

For optimal results, the Stem Cells Transplant Institute recommends the use of hUC-MSCs for the treatment of critical limb ischemia.

If the patient prefers, autologous mesenchymal stem cells derived from the patient’s own adipose tissue and bone marrow, can also be used to treat peripheral artery disease.

Treatment includes:

  1. 1cc vial of mesenchymal stem cells derived from human umbilical cord blood or bone marrow and adipose derived, autologous mesenchymal stem cells
  2. Antioxidant therapy with vitamin C and glutathione
  3. Ozone therapy
  4. Platelet-rich plasma therapy (PRP)

What are the advantages of human umbilical cord mesenchymal stem cells?

  • Abundant supply containing up to 10 times more stem cells than bone marrow or adipose derived stem cells
  • hUC-MSC have immunosuppressors and immunomodulatory properties that allow their use in any individual without rejection- Human Leukocyte Antigen (HLA) matching is not necessary
  • Greater proliferation ability than adult autologous stem cells
  • They regenerate at a very rapid rate
  • They have not been impacted by the aging process
  • They have not been affected by environmental toxins
  • Umbilical cord stem cells can be administered multiple times over the course of days
  • Eliminates the need to collect stem cells from the patient’s fat or hip bone reducing pain and recovery time

How are the stem cells collected?

Umbilical cord stem cells

We use only umbilical cord stem cells that are derived exclusively from umbilical cord donations. 

The umbilical cord stem cells from are collected after informed consent has been given by the parent, or parents, and only after the delivery of the baby.

The collection follows strict ethical protocols ensuring the stem cells are from safe, reliable sources using a non-invasive, simple and painless procedure. Once collected, the cord blood is then screened for disease.

Autologous adipose and bone marrow stem cells

On the day of the procedure, under local anesthesia and sterile conditions, a small sample of bone marrow is removed from the hip and a small of amount of adipose tissue (fat) is removed from the abdomen.

How are the stem cells administered?

The stem cells are administered intravenously and locally, into the affected limb, by subdermal and intramuscular injection.

About the Stem Cells Transplant Institute

Costa Rica has one of the best healthcare systems in world and is ranked among the highest for medical tourism.

Using the most advanced technologies, the team of experts at The Stem Cells Transplant Institute believes in the potential of stem cell therapy for the treatment of critical limb ischemia.

We are committed to providing personalized service and the highest quality of care to every patient.

Contact us to see if stem cell therapy may be a treatment option for you.

Scientific References:

1. Sun R.Advances in stem cell therapy for cardiovascular disease (Review). National Journal of Mol. Med. 38: 23-29, 2016

2. Martin Teraa, et. al., Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc. 2016;5:e002938 doi: 10.1161/JAHA.115.002938.

3. J. Yan, G. Tie, T. Y. Xu, K. Cecchini, and L. M. Messina, “Mesenchymal stem cells as a treatment for peripheral arterial disease: current status and potential impact of type II diabetes on their therapeutic efficacy,” StemCell Reviews and Reports, vol.9, no. 3, pp. 360–372, 2013. 4 Rita Compagna Cell Therapy in Patients with Critical Limb Ischemia Hindawi Publishing Corporation. Stem Cells International. Volume 2015, Article ID 931420, 13 pages