Buergers Disease

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Thromboangiitis obliterans or Buerger’s disease is a rarely occurring disorder characterized by obstruction of the blood vessels of the feet and the hands.

Causative factors
Thromboangiitis obliterans occurs as a result of inflammatory changes in the blood vessels, also called vasculitis.


It usually affects the vessels in the feet and the hands. The blood vessels are constricted or completely blocked, resulting in the reduced supply of blood to the hand and the foot tissues, causing severe pain and damage.
This condition affects about 6 out of every 10,000 people. It is more common in men between the ages of 20 and 40 years, especially those having a history of chewing tobacco and smoking.
A history of Raynaud’s disease is a common finding in patients suffering from Thromboangiitis obliterans.
The incidence of this disease is very rare in children. However, it may affect those suffering from autoimmune disorders.

TREATMENT LIST
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Symptoms
Red, bluish or pale hands and feet.
Coldness of the hands and the feet .
Pain in the feet and the hands that is:

  • Severe and acute
  • Tingling or burning
  • More at rest

Pain in the feet, ankles or legs while walking. This is called intermittent claudication.
The pain is usually felt in the arch of the foot.
Ulcers or skin changes on the hands and the feet.
Note: These symptoms usually worsen due to mental stress and exposure to cold. It usually affects two or more limbs.

Tests and Exams

Red, enlarged and tender blood vessels can be seen on the hands and the feet. The pulse in the feet or the hands is often absent or low.
The following tests can be conducted to determine blockages in the blood vessels of the affected feet and hands:
An arteriography or angiography of the extremities
A Doppler ultrasound
Some blood tests can also be performed to detect other causes associated with vasculitis and inflammation. A biopsy of the blood vessel may be needed in some cases where the diagnosis is not clear.

DETAILS

Regenerative Tissue Therapy (cells)
A broad outline for the eligibility, exclusion and inclusion criteria, are given beneath. But, the final decision to conduct Regenerative Tissue Therapy (cells) for any patient must be taken on a case to case basis after considering some exceptions to these guidelines.

It is recommended that umbilical cord and cord blood derived Regenerative Tissue Therapy (cells) be used instead of autologous Regenerative Tissue Therapy (cells) derived from bone marrow, adipose tissue, peripheral blood, skin, cornea, small intestine and liver. Nevertheless, the final decision can be taken only after studying and deliberating the medical history of the patient. Therefore, the selection of the Regenerative Tissue Therapy (cells) and their dose, the route of administration and the sources of the same should be decided on individual case basis.
It is advisable to administer GM-CSF before initiating the therapy in order to mobilize the autologous Regenerative Tissue Therapy (cells) from the patient’s bone marrow so that they act synergistically with the transfused ones.

The project director also advocates other supportive therapies including:
1] Hyperbaric Oxygen Therapy – In this procedure, hyperbaric Oxygen is administered to the patient in specialized Hyperbaric Oxygen chambers. This therapy is used for
– Enhancing oxygen carrying capacity of the blood.
– Increasing partial pressure of oxygen in the affected tissues of the body.
– Treatment of air embolism and De-compression sickness.
2] Chelation therapy is also indicated for the removal of heavy toxic metals such as iron (including in cases of thalassemia), mercury, arsenic, plutonium lead, uranium, and other forms of metal poisoning. The chelating agent can be administered orally, intramuscularly or intravenously, depending on the type of poisoning and the agent used.
Numerous chelating agents are available, each having a different affinity for different metals. The commonly used chelating agents are:

  • Dimercaprol (BAL)
  • Aminophenoxyethane-tetraacetic acid (BAPTA)
  • Alpha lipoic acid (ALA)
  • Ethylenediamine tetraacetic acid (calcium disodium versante) (CaNa2-EDTA)
  • Deferiprone
  • Deferasirox
  • Deferoxamine
  • D-penicillamine
  • Diethylene triamine pentaacetic acid (DTPA)
  • Dimercaptosuccinic acid (DMSA)
  • Ethylene glycol tetraacetic acid (EGTA)
  • Dimercapto-propane sulfonate (DMP

The project director strongly recommends using both chelation therapy as well as Hyperbaric oxygen therapy before beginning Regenerative Tissue Therapy (cells) procedure. This will give patients an advantage of better acceptance and engrafting of the infused Regenerative Tissue Therapy (cells) into the damaged tissues or organs. This will also help in faster repair of the treated part. This way, the benefits of Regenerative Tissue Therapy (cells) can be optimized. However, the decision to perform these procedures should be individualized on case to case basis.

Eligibility
– Age – up to 18-80 years
– Race – Any
– Sex – Any
– Ethnicity – Any

Inclusion criteria
– Preferably younger than 45 years of age.
– Recent or current historyof smoking or tobacco use.
– The presence of ischemia in the distal part of the extremities indicatedby pain at rest, claudication, ulcers or gangrene

andconfirmed by noninvasive vascular test.
– Phlebitis migrans or infrapopliteal arterial occlusions with involvement of eitherarm.

Exclusion criteria
– Presence of hypercoagulable states, diabetes mellitus or autoimmunedisorders confirmed by laboratorytests.
– Presence of emboli at theproximal source determined by arteriography or echocardiography with persistent arteriographic findings inthe clinically involved as well as noninvolved limbs.
Presence of high riskfactors for atherosclerosis (excluding smoking).

How It Works

Basic overview: Some basic principles that must be followed before the infusion of Regenerative Tissue Therapy (cells) (in case of frozen Regenerative Tissue Therapy (cells)) are mentioned beneath.

– The frozen Regenerative Tissue Therapy (cells) should be thawed in a warm water bath at 37o C by constant agitation.
– Precautions should be taken to avoid the exposure of the Regenerative Tissue Therapy (cells) to bright light while thawing.
– The Regenerative Tissue Therapy (cells) should be collected in a syringe using a wide bore needle (No. 18) to avoid damaging

the fragile Regenerative Tissue Therapy (cells). The syringe should be covered with a tape in order to prevent exposure to light.

– A 23 gauge needle can be used for the infusion. The infusion should be given slowly over a period of 3-5 minutes in dim light.
– Keep a check for immediate transfusion reaction.

Mode of Administration and Dosage of Regenerative Tissue Therapy (cells):

The dosage of Regenerative Tissue Therapy (cells) varies between 30 and 100 million Regenerative Tissue Therapy (cells) for generating positive results. However, sometimes a dose of even 1 million can be sufficient to generate desired response.
An intravenous administration of the Regenerative Tissue Therapy (cells) is recommended in most cases. However, we also recommend intramuscular, intra-arterial, subcutaneous, sub-dural, intrathecal, sub-arachnoid and intraocular administration in special cases and in some specific diseases. Direct on-site administration of the Regenerative Tissue Therapy (cells) at the site of injury can also be done using special interventional techniques or by direct on-site injection or implantation.
The decision regarding the exact dosage and appropriate mode of administration is best taken on a case to case basis after thorough deliberation on the cause and the extent of the ailment.

Treatment Details

Allogenic Umbilical Cord Derived

Each dose of umbilical Regenerative Tissue Therapy (cells) must be preceded by GM-CSF a day before their infusion in a dose of 5 micrograms per kg body weight in adults and 2.5 micrograms per kg body weight in children.

Mode of administration of GM-CSF:

As an intravenous (IV) infusion into the vein

As a subcutaneous injection under the skin

Side Effects of GM-CSF

Important points to understand regarding GM-CSF

– Most patients do not develop all of the listed side effects of the therapy.

– Most often, these side effects are reversible and resolve spontaneously after the treatment is over.

– The onset and duration of these side effects are fairly predictable.

– There are ways by which these side effects can be prevented or minimized.

– There is no direct relationship between the severity or the occurrence of the side effects and the positive outcomes of the therapy.

Common Side Effects of GM-CSF:

– After the first dose of GM-CSF is administered, patients may develop low blood pressure, abnormal flushing, fast heart rate, feeling faint and lightheadedness. This is called the “first-dose effect” and usually does not happen from the second dose onwards.

– Local manifestations at the site of injection, such as swelling, tenderness and redness may occur.

– Diarrhea

– Fatigue and weakness

Less Common Side Effects

– Flu-like symptoms such as fever, generalized pains, headache, fatigue and weakness

– Swelling in the feet and the hands

General points to be remembered in case of Regenerative Tissue Therapy (cells) obtained from cord blood and umbilical cord lining:

– CD 34+ cells for the purpose of discussion here are the cells akin to hematopoetic cells that carry CD 34+ markers, which are obtained from cord blood after isolation, by using cell sorting techniques or magnetic beads.

– Mesenchymal Regenerative Tissue Therapy (cells) for the purpose of discussion here are the cells akin to total nucleated cells that are derived from the cord lining procured following exhaustive processing.

Regenerative Tissue Therapy (cells) dose

32-80 million Mesenchymal Regenerative Tissue Therapy (cells) + 10 to 40 to million CD 34+ cells over a duration of approximately 1 year.

Duration : 8-20 million Mesenchymal Regenerative Tissue Therapy (cells) + 2.5 to 10 million CD 34+ cells over a duration of three months simultaneously with GCSF a day prior to Regenerative Tissue Therapy (cells) treatment.

The approximate total dosage of Regenerative Tissue Therapy (cells) should be 100-200 million in order to generate a favorable response.

Regenerative Tissue Therapy (cells): Route of Administration

Intravenous

Possible adverse effects caused by Regenerative Tissue Therapy (cells)

– Rash

– Mild Fever

– Headache

Quality Check

The cells should be checked for quality purposes to meet the following GMP and GLP standards:

HIV I AND II by PCR and ELIZA

HbsAG by PCR and ELIZA

HCV by PCR and ELIZA

Endotoxin content

Bacterial contamination

CMV

Or

Regenerative Tissue Therapy (cells) derived from Autologous Bone Marrow

– 150-200 ml of bone marrow should be collected in a blood bag under strict aseptic precautions in an operation theater by administering general anesthesia.

– Later, Regenerative Tissue Therapy (cells) should be processed and isolated as per GMP and GLP standards.

– The final volume of 5 -10 ml should be administered intravenously within 6-8 hours of collection.

Regenerative Tissue Therapy (cells): Route of administration

Intravenous

Or

Autologous Regenerative Tissue Therapy (cells) obtained from adipose tissues

– Approximately 150-200 ml of adipose tissue should be obtained in a blood bag by performing liposuction. The procedure should preferably be performed by a plastic surgeon in an operation theater, by administering general anesthesia.

– Regenerative Tissue Therapy (cells) should be processed and isolated as per the standards recommended by GMP and GLP.

– The final volume of 5 -10 ml should be administered via intravenous route within 6-8 hours of collection.

– As the Regenerative Tissue Therapy (cells) can not be checked for contamination, it is advisable to provide an antibiotic cover before the infusion.

Route of administration:

Intravenous

Or

Autologous Regenerative Tissue Therapy (cells) obtained from Peripheral Blood

– The Regenerative Tissue Therapy (cells) should be obtained by a procedure called “apheresis”.

– This procedure is performed in an ambient environment by using a well programmed cell separator (Hemonitics or Kobe Spectra) that provides the desired dose of Regenerative Tissue Therapy (cells) (approximately 200-250 ml) from the peripheral blood stream in a blood bag designed specially for the purpose.

– An infusion with GM-CSF (in a dose of 5 microgram per kg body weight in an adult and 2.5 microgram per kg body weight in children) prior to the procedure would help to ensure optimum mobilization of the Regenerative Tissue Therapy (cells) from the bone marrow.

Route of administration:

Intravenous

Or

Autologous Regenerative Tissue Therapy (cells) derived from cornea, skin, small intestine, teeth, liver, etc.

– The Regenerative Tissue Therapy (cells) can be procured from any of these organs by using sophisticated techniques that are performed under general anesthesia in an operation theater.

– Regenerative Tissue Therapy (cells) should be processed and isolated as per the standards of GLP and GMP.

– The final volume of 5-10 ml should be administered via intravenous route within 6-8 hours of the collection.

– Since the Regenerative Tissue Therapy (cells) cannot be tested for possible contamination, an antibiotic cover is highly recommended prior to the infusion.

Route of administration:

Intravenous

OR

Allogenic / Autologous therapy using Regenerative Tissue Therapy (cells) derived from amniotic fluid, placenta and / or amniotic sac

Different types of progenitor cell populations, such as mesenchymal, trophoblastic, hematopoietic and more primitive Regenerative Tissue Therapy (cells) can be isolated from the placenta and the amniotic fluid. Some of the placental and amniotic cells have a common origin, the inner cell mass of the morula. In fact, most forms of progenitor cells isolated from these 2 sources share multiple characteristics. The amniotic fluid and the placenta possess numerous progenitor cell types from the developing embryo, including the bone, the fat and the muscle.

Amniotic sac (amniotic membranes) and Placenta:

After harvesting blood cells simultaneously from placenta blood (UPB), placenta tissue (UPT) and umbilical cord (UCB) for their nucleated cells, CD34 (hematopoietic stem progenitor marker) positive cells, the outcome showed that the nuclear cell derived from UPT and UPB had 3-4 times than that derived from the UCB only. The nuclear cells from UPT (Placental tissue) and UPB (Placental Blood) had higher survival ability than the cells from UCB under the long-term cell culture conditions. When stored in liquid nitrogen, these cells did not show much loss of CD34 (+) cells and total nucleated cell count. It was also observed that UPB and UPT contained a higher number of suppressor lymphocytes, which could have high importance for minimizing the chances of graft-versus-host disease. The above implications strongly point to the importance of placental tissues and blood collection and processing together with UCB processing for Regenerative Tissue Therapy (cells) transplantation.

Amniotic fluid

Regenerative Tissue Therapy (cells) from amniotic fluid can be used for differentiating into adipose tissue, muscle, cartilage, blood vessel, bone, nerve, etc.

These cells serve as a valuable source for the repair of cells, tissues and organs in the body.

The Regenerative Tissue Therapy (cells) that are sourced from amniotic fluid are referred to as Amniotic Fluid Derived Stem (AFS) cells. These cells belong to a stage intermediate between the embryonic Regenerative Tissue Therapy (cells) and the adult cells. They are capable of self-renewal, the most characteristic property of Regenerative Tissue Therapy (cells). These cells can also be used for producing a wide range of cells that can be valuable for the therapy.

Amniotic Fluid Derived Regenerative Tissue Therapy (cells) can be found in amniotic fluid obtained from the procedures meant for examining cells for prenatal diagnosis of genetic diseases – this procedure is known as amniocentesis. One very common source of amniotic fluid is childbirth. The possibility of a perfect match is also high due to its primitive nature.

Advantages of AFS cells:

1) They can be obtained easily by performing amniocentesis.

2) These cells multiply and double once in every 36 hours. That means; they can be easily grown in huge quantities so as to generate enough Regenerative Tissue Therapy (cells).

3)’ Factors’ or ‘Feeders’ are not required to guide them for migrating towards the desired cell line.

4) These cells do not produce tumors; hence are largely preferred over embryonic Regenerative Tissue Therapy (cells).

5) Specialized cells that are generated from AFS cells comprise of all three types of cells existing in the developing embryo including endoderm, mesoderm and ectoderm. Hence, these Regenerative Tissue Therapy (cells) have a potential to differentiate into any organ, tissue or cell of the body.

6) Just like embryonic Regenerative Tissue Therapy (cells), Amniotic Fluid Derived Regenerative Tissue Therapy (cells) have the ability to generate all types of adult cells.

The project director advises using Regenerative Tissue Therapy (cells) from amniotic sac placenta and / or amniotic fluid. These cells should be processed carefully, isolated and then cultured in a clean room (as per GMP and GLP standards) and can be used for allogenic or autologous purposes just like the Regenerative Tissue Therapy (cells) isolated from cord tissue and cord blood. They can, at times, be used concurrently with chelation therapy and / or hyperbaric oxygen after administration of GM- CSF. The selection of Regenerative Tissue Therapy (cells), its dosage, mode and route of administration, accompanying adjuvant therapy etc. vary depending on individual case.

Route of administration of Regenerative Tissue Therapy (cells)

Intravenous

Common side effects of amniotic Regenerative Tissue Therapy (cells) treatment

– Rash

– Mild Fever

– Headache

Quality Check

The cells are quality checked for the below mentioned GMP and GLP standards:

HIV I AND II by PCR and ELIZA

HbsAG by PCR and ELIZA

HCV by PCR and ELIZA

CMV

Endotoxin content

Bacterial contamination

Complications that may occur due to Buerger’s disease

Gangrene or tissue death
Loss of blood circulation beyond the affected part of the extremity
Amputation

When should one contact a healthcare professional?

Consult a healthcare expert if you have noticed the signs and symptoms of thromboangiitis obliterans, if you have thromboangiitis obliterans and the signs get worse in spite of taking treatment or in case new symptoms develop.

Prevention

Those with a history of thromboangiitis obliterans and Raynaud’s disease should strictly avoid tobacco use.

Alternative Names

Buerger’s disease

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