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What is Critical Limb Ischemia?

Ischemia, by definition, means insufficient blood supply. When used in connection with limbs, it refers to a condition so severe that it puts the legs at risk for amputation. A blockage of blood going to the lower extremities is critical enough to leave the limb dying due to lack of circulation.
How does this happen? There are a number of medical problems that lead to critical limb ischemia (CLI), including infection and peripheral artery disease or hardening of the arteries. Diabetes is a common risk factor for CLI, as well, because it has a direct effect on circulation and healing. The goal of any CLI treatment such as stem cell therapy is to improve the quality of the patient’s life.

What is CLI Stem Cell Therapy?

CLI stem cell therapy is a cutting-edge treatment option that uses the patient’s stem cells to improve quality of life and minimize disease-related symptoms. Patients receive this CLI treatment in two ways:

  • As a systemic IV infusion that sends stem cells to the entire body
  • As a focused localized injection into the affected limb

Stem cells are cells that have not decided what to be yet. In this undifferentiated state, they have the ability to become any cell such as neurons, bone, cartilage, muscle and tendon. Critical limb ischemia stem cell treatment offered as part of TruStem Cell Therapy™ uses adipose, fat tissue stem cells because they are easily available and possess a higher immunomodulatory capacity, making them safe to use in this way.
Through TruStem Cell Therapy™, the stems cells are safely removed from the patient’s body and redistributed to the area in need. With critical limb ischemia treatment, that would be the lower limbs.

Why is CLI Stem Cell Therapy Helpful?

Stem cell therapy is helpful as a critical limb ischemia treatment because it may minimize disease-related symptoms and reduce complications such as tissue death. Our critical limb ischemia patients see improvements in many ways:

  • Improved blood flow to the extremities
  • Reduction in pain
  • Fewer skin ulcers and sores
  • Less fatigue

Of course, there are no guarantees with any form of medical treatment, but stem cell therapy is emerging as a viable alternative to many traditional options. Although not FDA approved as a therapy for critical limb ischemia, studies show that it is a safe and efficient CLI treatment worth considering. We provide each patient with a skilled advocate trained to provide them with realistic expectations of this treatment.

How Does the Critical Limb Ischemia Stem Cell Treatment Work?

There are three key steps involved in the TruStem Cell Therapy™ therapeutic process:

  • Harvesting of around 150 to 250 ccs of fat tissue — Since it is taken directly from the patient, there is no risk of disease or rejection. The harvesting process is minimally invasive, removing tissue from the abdomen region much like liposuction.
  • Processing of the fat tissue — Once removed, the harvested tissue goes to the on-site lab for processing. The goal at this stage is to isolate the stem cells and activate them using a process unique to TruStem Cell Therapy™.
  • Administering the treatment — The harvested and activated stem cells are given back to the patient to treat the ischemia. The administration includes both the systemic IV infusion and the targeted local injections to saturate the body with stem cells.

These three steps — harvesting, processing and administration — work together to help patients with CLI find relief from the symptoms such as:

  • Cold skin
  • Chronic wounds
  • Muscle pain

Stem cell therapy uses the body’s healing mechanisms to offer improvement safely and quickly. Although there is no set timeline for changes based on stem cell therapy, you might expect to see noticeable results in just a few weeks, or it could take months. Everyone responds differently.
Ischemia in the legs presents in two ways: (1) There can be a continuous burning pain in the lower leg or feet that gets worse when the limb is elevated, or (2) ulcers and tissue loss. If you have either problem, seek treatment immediately. CLI is a very serious condition that requires medical care, and we want to help. Give us a call to schedule an appointment with one of our patient advocates today.

There are two types of CLI:

Rest Pain

is a continuous burning pain of the lower leg or feet. It begins, or is aggravated, after reclining or elevating the limb and is relieved by sitting or standing.

Tissue loss

is the development of arterial insufficiency ulcers or gangrene due to peripheral artery disease


What are some Potential Symptoms/Complications resulting from CLI?

Bluish skin

Muscle pain while walking

Resting pain

Cold skin

Poor nail and hair growth

Chronic wounds (non-healing wounds)

Tissue necrosis



High mortality risk


What Causes Critical Limb Ischemia?

CLI is the end result of arterial occlusive disease, most commonly atherosclerosis (the build-up of fats, cholesterol and other substances in the artery walls). Diabetes is a particularly important risk factor because it is frequently associated with severe peripheral arterial disease.

TruStem Cell Therapy™

What type of stem cells are used and why?

TruStem Cell Therapy provides access to treatment that utilizes a patient’s stem cells isolated from their own bone marrow. There are multiple inherent benefits afforded by the utilization of bone marrow derived stem cells including their ability to differentiate into a broad variety of cells types (neurons, bone, cartilage, muscle, tendon, etc.), they are present at comparatively much higher levels than other stem cell types, possess unique immune-modulating properties, and they do not endanger a patient’s health the way other stem cells might.

What steps are involved in receiving treatment through TruStem Cell TherapyTM?

There are three steps involved:
  1. Harvest

    First a blood draw is performed followed by a minimally invasive bone marrow harvest via the iliac crest. Approximately 100cc’s of a patient’s own bone marrow is harvested through a minimally invasive, bone marrow aspiration procedure. TruStem Cell Therapy utilizes a powered bone marrow access system combined with local anesthetic allowing for consistently larger specimen of cells, extremely low levels of pain/invasiveness reported by most patients, and higher levels of sterility.


    ● Bone marrow aspirate is preferentially utilized because it is one of the richest, most accessible sources of stem cells in the human body and falls within the FDA guidelines of minimal manipulation.

  2. Process + Activate

    Both the blood and bone marrow are immediately delivered to our dedicated, onsite laboratory staffed by our team of technicians. Once your sample is in the lab our advanced proprietary process isolates and excites regenerative cells and concentrates healing factors to hyper-physiological levels in order to facilitate the creation of a highly effective, injectable therapeutic.


    ● Stem cell activation is part of what makes TruStem Cell Therapy unique. The activation procedure is designed to augment efficacy.

  3. Administer

    TruStem Cell Therapy utilizes both systematic and novel administration methods to fully saturate the body with stem cells while targeting specific areas of injury.

How are stem cells administered back into Critical Limb Ischemia patients through TruStem Cell Therapy?

Critical Limb Ischemia patients who receive stem cell therapy through us can receive both systemic and targeted administration methods:

  • Systemic IV infusion of their stem cells to fully saturate the entire body.

  • Localized injections of the stem cells directly into each of the affected limbs

What is unique about receiving treatment through TruStem Cell Therapy™ for CLI?

  • Our focus is safety, efficacy, and patient-centric care when providing access to superior stem cell therapy.

  • We utilize only board certified surgeons, physicians and accredited clinicians to provide care for patients.

  • Laboratory protocols are developed and refined by our PhD Neuroscientist.

  • A clinical team with expertise in practicing cellular-based medicine

  • Accredited Surgical Centers for enhanced procedural and patient safety

  • Targeted administration methods that direct stem cells toward specific areas of injury.

  • Skilled Patient Advocates who are trained to provide truthful, realistic expectations resulting from stem cell therapy. We do not make outlandish promises of cures or inaccurate claims related to improvement rates.


Can this treatment cure CLI?

It is important for patients and caregivers to understand that current therapies, including stem cell treatment, may not provide a cure for CLI. However, TruStem cell therapy does have the potential to improve a patient’s quality of life by reducing symptoms and complications related to CLI as well as slowing its progression.

Are stem cells FDA approved for CLI?

The FDA has not approved stem cell therapy for CLI.  As noted above, studies have demonstrated the safety and efficacy of stem cell therapy for this condition but additional studies are needed before FDA approval can be secured.

What type of improvements can I expect from stem cell therapy?

It is possible through these treatments, to improve a patient’s quality of life by minimizing disease related symptoms and complications.  For Critical Limb Ischemia patients, it is possible to see improvements in any one or multiple disease related complications such as: reduced blood flow to extremities, pain, skin ulcers, sores, fatigue etc…  If you have questions regarding how these treatments may help you, please contact one of our Patient Advocates to learn more

How long will it take to see improvements?

It is difficult to predict the timeline of a patient’s response. Every patient responds differently to treatment. It could take weeks to months for the stem cells to provide noticeable results.

What type of side effects can a patient expect from stem cell therapy?

Typically patients will experience some level of soreness and bruising lasting roughly a week as a result of the bone marrow harvesting procedure. Additional complications have not been observed. Over a hundred studies and clinical trials have demonstrated the safety and minimal side-­effect profile of stem cell therapy.

Let’s discuss your options.