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Amyotrophic lateral sclerosis (ALS), also identified as Lou Gehrig’s disease is a serious neurological disorder that affects nerve cells present in the central nervous system and spinal cord. These cells primarily regulate voluntary muscle movement.


Worldwide, ALS affects 1 in every 1, 00,000 persons. In this progressive illness, the nerve cells or neurons gradually degenerate or die. As a result, they are unable to transmit messages to the muscles. Eventually, it brings about muscle twitching and weakening, which hampers movement of the arms or legs and even causes slurring of speech.

DETAILS

A Comprehensive Insight into Regenerative Tissue Therapy (cells)

Given below is a broad summary of Regenerative Tissue Therapy (cells) including
A) Eligibility,
B) Inclusion and exclusion standards

However, one must also consider certain exceptions to these recommendations. The final decision while selecting any patient for this treatment will totally rest on the project leader on a case to case basis.

In order of preference, the project director promotes umbilical cord and cord blood derived Regenerative Tissue Therapy (cells) instead of autologous Regenerative Tissue Therapy (cells) obtained from sources such as adipose tissue, skin, bone marrow, liver, small intestine, peripheral blood, cornea (limbus), etc. Nevertheless, the ultimate decision is taken after an inclusive study of the patients’ medical history and consequently the selection of Regenerative Tissue Therapy (cells), proper dosage, precise method of administration and its source are rationally chosen. Before utilizing Regenerative Tissue Therapy (cells), the director suggests using two relevant treatments, namely:

1. Hyperbaric oxygen therapy, which is carried out by administering hyperbaric oxygen in special hyperbaric oxygen chambers. This treatment is used to:

  • Treat air embolism or decompression sickness
  • Boost oxygen holding capacity of blood
  • Maximize partial force of oxygen in damaged tissues of the body

2. Chelation therapy is undertaken to remove toxic heavy metals such as mercury, lead, iron (comprising of thalassemia cases), uranium, arsenic, plutonium and additional forms of poisonous metals. The chelating agent might be given orally, intravenously or intramuscularly depending on the agent and the kind of toxicity.
Numerous chelating agents are offered that possess different similarities for varied metals. Some of the common ones are:

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

The chief reason behind this recommendation is that once these therapies are performed, infused Regenerative Tissue Therapy (cells) can be accepted effectively and implanted in the damaged organ or tissue, which in turn facilitates swift repair. In this way, the benefits of Regenerative Tissue Therapy (cells) are fully optimized. Nonetheless, such procedures are also established on a case to case basis. Another important advice that is advocated is administering GM-CSF (Granulocyte-macrophage colony-stimulating factor) prior to treatment in order to assemble the patient’s autologous Regenerative Tissue Therapy (cells) from the bone marrow and to work in synergy with the infused ones.

A) Eligibility:

Both genders of any race and ethnicity can take part in the study, however it does not accept healthy volunteers. The age group for most trials is 18-85 years.

B) Inclusion and Exclusion Criteria:

An important inclusion benchmark for enrollment is that a person should have ALS. He or she must be between 18-85 years of age with adequate evidence of progression of the ailment for duration of 6 months to 5 years. No other specific governing requirements are needed for signing up for the experiment.
Few conditions in which patients may be excluded for the study are:

  • Patients with extremely acute sensory or motor abnormality, psychiatric conditions, history of substance abuse, dementia, uncompensated medical sickness or other severe neurological ailments.
  • Individuals who are part of a concurrent drug research.
  • People suffering from chronic pre-existing breathing illnesses not connected to ALS to make sure that the Regenerative Tissue Therapy (cells) effect to offset the disease isn’t forfeited.

Some Basic Principles to Follow:
Mentioned below are few fundamental norms to be adhered to in case of frozen Regenerative Tissue Therapy (cells):

1. The cells need to be thawed first in a 37 degrees Celsius water bath with constant agitation. During this process, ensure that the Regenerative Tissue Therapy (cells) are not subjected to bright light.

2. Collect the cells in a syringe. Using a wide bigmouth needle (No.18) to avoid damaging the delicate cells, conceal the syringe with a tape to avert light exposure.

3. This infusion is required to be administered over a span of 3-5 minutes in dim light by utilizing a 23 gauge needle.

4. Post transfusion, immediately check for any reaction.

Correct Dosage and Administration of Regenerative Tissue Therapy (cells):
Dose varies for every case. Generally, a range of 30-100 million Regenerative Tissue Therapy (cells) is needed to produce a positive response. But at times even a low dose of 1 million could be sufficient to create a positive outcome.
Intravenous route is suggested in majority of cases. Nonetheless, for specific or special conditions, intramuscular, intra-arterial, sub-dural, subcutaneous, intraocular, intrathecal, sub-arachnoid, etc. may be prescribed. Another way is direct on-site transfer of Regenerative Tissue Therapy (cells) at the exact location of injury either through direct transplant (or injection) or by using unique intervenous methods.
It may be noted that the final choice regarding the dose and administration mode of Regenerative Tissue Therapy (cells) is taken only after carefully understanding the cause and magnitude of the related illness, which can differ from case to case.

How It Works

Management of ALS:
Although an effective cure is not established yet for this problem, a FDA approved medication riluzole is useful in slowing the progression of ALS and prolonging survival. However, it does not reverse or prevent it from worsening.
The primary goal of treatment is controlling the signs. Spasticity, which makes it difficult to perform daily chores owing to excessive stiffness or contraction of muscles can be handled with medicines such as baclofen or diazepam. Similarly, individuals who have troubles gulping their own saliva may be prescribed to take amitriptyline or trihexyphenidyl.
Some other devices and therapies that aid to manage the signs of ALS and assist people to be independent are:
1. Physical rehabilitation such as using a wheelchair, braces or additional orthopedic means help to boost muscle function and overall health.
2. Patients who suffer from choking, a common sign of ALS might undergo gastrostomy wherein a tube is surgically inserted into the stomach for nutritional support. Since the illness tends to maximize the need to eat and given the inability to swallow, a nutritionist should be consulted to maintain a healthy weight.
3. Breathing can be enhanced with the use of special devices, which can be used at night in addition to constant mechanical air circulation. Patients can also have a conversation with their family members and physician about the need to have artificial ventilation.

Treatment Details

Detailed Procedure of:

A)  Administering Allogeneic Umbilical Cord & Cord Blood derived Regenerative Tissue Therapy (cells):

ALS

1. Every dose of these Regenerative Tissue Therapy (cells) has to be preceded by administration of GM-CSF 1 day before the infusion. The dose is 5 mcg (microgram) for every kilo of body weight of an adult and 2.5 mcg per kg body weight of a child.

2. GM-CSF is given either subcutaneously (injected beneath the skin) or intravenously (infused into the vein)

3. Before talking about the side effects experienced as result of administering GM-CSF, it’s essential to remember the following points:

  • Most individuals will not undergo all of the negative effects listed.
  • Such undesirable signs are practically always reversible and disappear once treatment ends. Moreover, they are often foreseeable with regards to their occurrence and duration.
  • One can inquire about several options, which aid to prevent or minimize the unpleasant symptoms.
  • There is no correlation between the presence or acuteness of the side effects and the efficacy of the drug.

Some common side effects, which are generally undergone after the 1st dose of GM-CSF, include fast heart rate, low blood pressure, faintness or flushing. This is also indicated as ‘first-dose effect’ which is not likely to take place with future doses. Other signs are diarrhea, weakness, exhaustion and local reactions at the place of injection.

Side effects, which are less common, comprise of minor flu-like symptoms (headache, weakness, fever and general body pain), swelling in hands and feet.

4. It is crucial that the cells undergo several quality assurance tests under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. These tests are:

  • Bacterial contamination
  • CMV
  • Endotoxin content
  • HIV I and II by ELIZA and PCR
  • HCV and HbsAG by ELIZA and PCR

5. A couple of points to bear in mind prior to infusing Regenerative Tissue Therapy (cells) derived from umbilical cord lining and cord blood are:

–       CD (cluster of differentiation) 34+ cells needed for the study are essentially cells similar tohematopoietic cells holding CD 34+ markers. These are gotten from cord blood after segregation using magnetic bead or cell grouping methods.

 

–       Mesenchymal Regenerative Tissue Therapy (cells) (MSCs) required in this research are analogous to complete nucleated cells obtained from cord lining, which is acquired following extensive processing.

6. Dosage of the Regenerative Tissue Therapy (cells) is as follows:

  • 32-80 million MSCs plus 10-40 million CD 34+ cells over a duration of 1 year
  • 8-20 million MSCs plus 2.5-10 million CD 34+ cells over a span of 3 months (along with GM-SCF 1 day before Regenerative Tissue Therapy (cells))
  • A total dosage amount of around 100-200 million Regenerative Tissue Therapy (cells) is sufficient to bring about favorable response

7. The cells are given through an intravenous route. Known side effects that can happen with this therapy include headache, mild fever or rash.

OR

B) Autologous Bone Marrow derived Regenerative Tissue Therapy (cells):

1. The first step is to collect 150-200 ml of bone marrow in a blood container in a sterile environment. The procedure is performed in an operating theatre (OT) under general anesthesia.

2. The Regenerative Tissue Therapy (cells) are processed and separated in accordance with GLP andGMP norms. Since these cells cannot be examined for any bacterial contagion, an antibiotic cover before implantation is essential.

3. Lastly, a volume of 5-10 ml is administered intravenously within 6-8 hours of accumulation.

C) Autologous Regenerative Tissue Therapy (cells) obtained from Adipose Tissue:

1. By means of liposuction, 150-200 ml of adipose tissue is accumulated in a blood bag. The surgical operation is preferably done by a plastic surgeon in an OT under local anesthesia.

2. The procedure followed for processing and isolation is exactly the same as bone marrow derived cells. In absence of microbial contamination checks, an antibiotic cover prior to transplanting is needed as well.

3. A final quantity of 5-10 ml is infused via intravenous method within 6-8 hours of collecting the cells.

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

1. Sophisticated practices are employed to derive Regenerative Tissue Therapy (cells) from any of these body parts. The patient is taken to an operating room for the task and given general anesthesia.

2. The rest of the steps with regards to cell processing, isolation, quality standards, final quantity of cells and route of administration is same as those followed in case of bone marrow and adipose tissue.

E) Autologous Peripheral Blood derived Regenerative Tissue Therapy (cells):

1. A process termed as ‘apheresis’ is performed to gather the Regenerative Tissue Therapy (cells). It is conducted in ambient surroundings with the assistance of a well-automated cell separator such as CobeSpectra or a Haemonetics blood management device.

2. The desired Regenerative Tissue Therapy (cells) (around 200-250 ml) are procured from the blood stream and accumulated in a specially designed blood container.

3. GM-CSF is given prior to implantation in order to ensure optimal utilization of vital Regenerative Tissue Therapy (cells) from the bone marrow. The dosage is 5 mcg per kg body weight for grown-ups and 2.5 mcg/kg body weight for children.

4. Mode of administration adopted for grafting the Regenerative Tissue Therapy (cells): Intravenous

The project leader also encourages Regenerative Tissue Therapy (cells) acquired from placenta, amniotic fluid. Such cells are cautiously processed, separated and cultivated in a hygienic room as perGLP and GMP norms. They could be used for allogenic or autologous purposes just like Regenerative Tissue Therapy (cells) that are gotten from cord blood/tissue.

At times, Regenerative Tissue Therapy (cells) mentioned earlier, namely hyperbaric oxygen therapy and/or chelation therapy, may be carried out concurrently following GM-CSF administration. For placenta or amniotic fluid derived Regenerative Tissue Therapy (cells) too, factors such as selection of cells, correct dosage, administration method, accompanying additional treatment, etc. differ for each case.

F) Allogenic/Autologous therapy utilizing Regenerative Tissue Therapy (cells) from Placenta or/and Amniotic Fluid:

1. Various predecessor cell groups including mesenchymal, trophoblasts, hematopoietic and perhaps some more primal Regenerative Tissue Therapy (cells) could be isolated from the placenta and amniotic fluid.

2. Some of the placental and amniotic cells have a common origin i.e. the internal cell mass of themorula. In fact, most forms of progenitor cells that can be segregated from these 2 sources share several characteristics. The placenta and amniotic fluid comprise of multiple precursor cell types from the maturing embryo containing bone, fat and muscle.

3. After concurrently reaping blood cells from umbilical cord blood, placenta tissue and placenta blood to acquire genetic matter from nucleated cells and CD34+ cells, the results indicated that the nucleated cells from the placenta tissue and placenta blood had 3-4 times higher survival ability in the long-term as compared to cells obtained from only umbilical cord blood.

4. Storing these cells in liquid nitrogen didn’t exhibit huge loss of overall nucleated cell count and CD34+ cells. It was noted that placenta tissue and placenta blood had greater suppressor lymphocytes that could be important in avoiding graft-versus-host disease. Such effects imply the significance of placental blood and tissue accumulation, combining it with umbilical cord blood and processing them together for Regenerative Tissue Therapy (cells) implantation.

G) Amniotic Fluid derived Regenerative Tissue Therapy (cells) (AFSC) or Amniotic Sac derived Regenerative Tissue Therapy (cells) (ASSC):

1. Regenerative Tissue Therapy (cells) gotten from amniotic fluid and amniotic sac possess the distinct capability to differentiate into adipose tissue, blood vessel, muscle, cartilage, nerve, bone, etc. The cells are a beneficial resource for organ, cell and tissue repair or restoration.

2. Amniotic fluid derived Regenerative Tissue Therapy (cells) (AFSC) may be an intermediary stage between developing Regenerative Tissue Therapy (cells) and adult cells. They have the ability of self-regeneration, which is their defining property. In addition, they could also be employed to produce an extensive range of cells that can be useful for therapy.

3. These cells can be obtained from abundant sources of amniotic fluid through a medical procedure termed as amniocentesis, wherein cells are examined for prenatal diagnosis of certain genetic abnormalities. Childbirth is considered the most effective source of amniotic fluid and amniotic sac. Due to its embryonic nature, chances of a perfect match are quite likely.

4. Some advantages of AFS cells are:

  • Easily attainable by means of amniocentesis.
  • Since these cells double after every 36 hours, they could be developed in greater amounts in order to produce large quantities of Regenerative Tissue Therapy (cells).
  • ‘Feeders’, i.e. special cells utilized for embryonic Regenerative Tissue Therapy (cells) research aren’t required to direct AFSC to travel towards the wanted cell line.
  • They don’t cause tumors and are therefore favored over budding Regenerative Tissue Therapy (cells).
  • Specific cells produced from AFS cells contain all 3 kinds of cells which are present in the maturing embryo viz. ectoderm, endoderm and mesoderm. Thus, these Regenerative Tissue Therapy (cells) could potentially segregate into any organ, cell or tissue of the human body.
  • Just like embryonic Regenerative Tissue Therapy (cells), AFSCs too possess the capability of generating each class of adult cell.

5. Amniotic cells need to be tested for their quality as per GLP and GMP norms. Following are the quality checks to be conducted:

  • Bacterial contamination
  • CMV
  • Endotoxin content
  • HIV I and II by ELIZA and PCR
  • HCV and HbsAG by ELIZA and PCR

6. The amniotic Regenerative Tissue Therapy (cells) are administered via the intravenous route. Minor temperature, rashes or headaches are some of the side effects that might be experienced post treatment

FAQS

What are the Benefits of Regenerative Tissue Therapy Therapy?

Regenerative tissue therapy, also known as Stem Cell Therapy,helps in the repair,healing and regeneration of damaged or injured tissues. It regeneratestissues that are injured due to meniscal tears, rotator cuff tears, ligament tears, tennis elbow and degenerative diseases such as arthritis and osteoarthritis. It reduces pain caused due to injury and improves performance. The treatment is performed in theoffice, under local anesthesia. This eliminates any risks associated with anesthesiaor surgery.

How do I know Whether this Therapy is Good for Me?

For this, you should consult your doctor if you suffer from any degenerative diseaseor have any type of joint pain. Regenerative Tissue Therapyallows the patient’s body to use it’s own cells for healingand repairing damaged tissue.

Are there any Ethical Issues involved with Adult Cells?

Not at all. Adult Regenerative tissue cells are not embryosand donot have the potential to develop into a human being. They reside within the bone marrow as well as the fatlayers,and exist in large quantities.

Does the Therapy Involve any Side Effects?

Regenerative Tissue therapy is an extremely safe procedure. Following a complete medical evaluation, our specialists determine whether you are theright candidate for this treatmentor not. A few patients might experience some pain and soreness during the post-operative period. Since fat and autologous blood is used, there are minimal chances of an allergic reaction.

What’s the Difference between Cells from Bone Marrowand Fat?

Both bone marrow and adipose cells belong to a type of adult cell calledMesenchymal Cells. Bone marrow derived cells are collected from the hipboneand adipose cells are collected through a mini liposuction procedure. The bone marrow cells possess a superior ability to repair as well as differentiate into ligaments, bone and cartilage.Adipose cellson the other hand have regenerative properties to produce new blood vessels, a process which is important for the delivery of nutrients and oxygen to the tissues.

How do I know Whether the Cells are injected in the Right Place?

We know that the success of any treatment depends upon a reliable delivery system. We put to use a simple injection in and out method, in order to deliver the cells. Also, our injections are all done under X-Ray (fluoroscopy) to visualize the site of injury as well as provide effective and accurate treatment.

What is PRP and why is it used along with Regenerative Tissue Therapy?

PRP is blood plasma which containsa high autologous concentration of cells known as platelets. These cells release growth factors as well as other proteins which promote healing of wounds in bone and soft tissues. When PRPis injected, the high concentration of platelets delivers a powerful dose of growth factors that helps to accelerate and enhance the repair and healingof tissues. In addition, these growth factors attract regenerative cells to the injury site. While injecting PRP, more than 1injection is recommended in order to maximize results.

How is PRP Derived?

PRP is obtained using a safe and simple blood draw. For collection, special collection tubes are used and approximately 16 cc of blood is obtained. The collected blood is centrifuged using special equipment until the PRP is obtained. Following this process,PRP is ready to be injected or mixed along with fat for aesthetic enhancement.

Is there any Special Procedure to prepare for when undergoing PRP or Regenerative Tissue Therapy?

Prior to treatment, patients are encouragedto undergo a simple detox in order to prepare the body to be better conditioned for receiving the regenerative cells. Patients mustcease smoking and alcohol consumption at least 1 week before the procedure. An IV Vitamin Therapyis recommendedto clean the system oftoxinsand simultaneously infuse vitamins as well as minerals in the bloodstream. The vitamins are required by some cells to perform important functions. Possessing a good balance of such vitamins will improve the effectsof the treatment.

When can I Resume Work and Routine Activities?

The treatment is ambulatory. Generally, patients are sore during the first couple of days after the injection. They can resume work after 2 to 3 days, depending upon the site of treatment as well as the levelof physical activity required from patientsat their respective jobs.

Is the treatment approved by the FDA?

There is no clear protocol to treat any disease using adult cells in the U.S. With advancements in science and more research, the laws and regulations in the field of regenerative medicine have been changing quite rapidly. Even though the therapyis not regulated by the FDA, we ensue that we follow the standard regulations for patients’safety as well as safe laboratory practices.

PRECAUTION

Consulting

  • Before doing any treatment please consult your doctor to confirm if the treatment is the right one for you
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