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Stem Cell Treatments for Incurable Disease

AmStem’s subsidiary, Histostem Ltd. of South Korea, has enjoyed a unique position in the world of stem cell research for a number of years. In February 2007, they received approval from the Korean FDA to use stem cells as a “surgical technique” to treat virtually any emergency condition.

Buoyed by this unprecedented regulatory support, Dr. Hoon Han of Histostem has partnered with leading researchers at the finest hospitals and universities in Korea, to study the treatment of intractable disease using non-controversial stem cells derived from umbilical cord blood. While using his patented techniques to prepare and treat patients, Dr. Han and his research team have compiled a significant body of research data that is unique in the world.

The initial data shows some exciting successes, and AmStem will be validating these early results with controlled clinical trials designed to the highest international (ICH) standards.

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Almost 800 Patients Treated in Clinical Trials

Click on one of the conditions listed in the table below for more information.
CONDITION PHASE PATIENTS
TREATED
Anti-aging Phase 1-2 500+
Alopecia (baldness) Phase 2 56
Diabetes Phase 1-2 37
Liver Cirrhosis Phase 2 31
Cerebral infarction Phase 2 24
Buerger’s Disease Phase 2 18
ALS Phase 2 12
Spinal Cord Injury Phase 1-2 10
Heart Disease Phase 1 5
Chronic Renal Failure Phase 1 5
Crohn’s Disease Phase Phase 1 1
Parkinson’s Disease Pending 0
Alzheimer’s Disease Phase 1-2 4
Multiple Sclerosis Phase 1 1
Osteoporosis Phase 1-2 6
Other Phase 1-2 --


Some of Dr. Han’s publications can be viewed on AmStem’s Publications page. Additional information is available on request.
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ClinicalTrials3WhoWeAre

Promising Results Means More Research Is Needed

The main reason for performing research is to find new treatments for disease. Dr. Han’s initial treatments and following of patients’ conditions is the most basic form of research, but the results have been very promising. Phase 1 research typically looks at whether a treatment is safe, i.e. if there are any side effects in normal, healthy individuals. In treating over 700 patients, Dr. Han and his colleagues have reported NO side effects that can be directly attributed to stem cell therapy.

Phase 2 research typically gathers more safety information, and begins to study efficacy of the treatment in a population that includes patients with the indication. The remarkable successes documented by Dr. Han and his team strongly indicate a promising degree of efficacy. AmStem’s management has over 30 years combined experience in creating, monitoring, and running clinical trials, and will use this expertise to set up studies that not only treat patients who have run out of options, but collects scientifically valid data that will meet or exceed international standards.

ClinicalTrials1DrStark
David Stark, President of AmStem Intl., Dr. Hoon Han, President of Histostem,
and Mr. Lee Sang Yong, Deputy Commissioner of the Korean FDA, in 2008.

KFDA Approval – What This Means for Patients

Here, in Dr. Han’s own words, is an overview of some of the results achieved by Histostem’s patented techniques:
“Stem Cell Therapy by Histostem is not merely confined as a providing of stem cells. Its use has also been documented through clinical tests related to several diseases listed below, since Stem Cell Therapy is approved by KFDA as a procedure of the doctors’ practice; not as a medication. This means that those who suffer from incurable diseases and patients who were unable to get any improvement from other existing medication or operations, are able to be treated by our Stem Cell Therapy method (as long as the patients and their doctors agree to do so). Thus, Stem Cell Therapy can be easily started for patients here in Korea KFDA’s approval of the stem cell therapy as a treatment method.”
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Impressive Clinical Trial Results

Spinal Cord Injury: Exposure by surgery and then stem cell injection at cord directly

“The results of spinal cord injury patients treated by Stem Cell Therapy method brought meaningful consequences – having an effect on the sensory nerves as well as motor nerves. In the case of one patient (who was featured in an international news story in 2008), she presented with a complete lower half of her body paralyzed, due to C 6-7 fractures from a car accident and resulting spinal cord injury. But after Histostem’s Stem Cell Therapy, she had noticeable changes:
  1. Change of Automomic Nerve:
    Before Stem Cell Therapy, she suffered from constipation, but after Stem Cell Therapy, her bowel habits started to change for the better. She was able to relieve excreta, her bowel movement became soft, and she could feel full after meals. We also recorded data that that her bladder filled up and her blood pressure was increasing from pain stimuli.
  2. Sensory Nerve:
    The numbness of upper limbs went back to normal, temperature sense and pain sense in the lower limbs got better than before.
  3. Motor Nerve:
    On the 22nd day after treatment, she started a movement of her toes, and with assisting equipment, she could keep herself to stand up.
Other than that, in the case of a 20 year old male patient from Croatia, in January 2003, he got a complete lower half of his body paralyzed from a car accident, but after Stem Cell Therapy, he was able to balance his body using his back muscle only (without use of his hand muscles) and also to move his own toes and he recovered his sensory nerve and motor nerve which made him take on and off his artificial legs.”
Clinical Trials Stem Cell Therapy Spinal Cord Injury


Spinal Cord Thesis

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Diabetes (Type II): I.V. injection

“As a result of treatment, glucose levels in blood vessels became reduced and was stabilized. The reduction of glucose levels demanded less insulin, which resulted in conversion from diabetes medical treatment of insulin to the insulin-free medication. And also Stem Cell Therapy has a great effect on prevention and cure of complications of retinopathy and nephropathy from diabetes.”

Buerger’s disease: Injection by subcutaneous

“Buerger’s disease is an incurable disease that blocks the blood vessels, leading to amputating the limbs in the worst cases. The incidence of Buerger’s is high in Asia; for example, 60% of telangiectasia is actually Buerger’s disease in Indonesia. Therefore, Buerger’s disease is a disease with a big market size. This Buerger’s disease is treated by a direct Stem Cell Therapy injection to the affected blood vessels.”
Buerger’s disease: Injection by subcutaneous


Buerger's Disease Thesis


Chronic renal failure: I.V. injection (Before hemodialysis; creatinine below 5.0)

“Before blood injection and in the case of patients with Creatinine below 5, we confirmed the complete kidney recovery. Additionally, in the case of patients with renal insufficiency, we also witnessed a direct protection effect from repeating-injection of stem cells.”
Kidney_2-W

Liver Cirrhosis: Direct injection at liver parenchyma

“We have verified the effects below in the case of patients with liver hard excrement:
  1. Decreased liver enzyme
  2. Decreased ammonia
  3. Increased albumin level
  4. Improved the whole physical condition
  5. Induced sound sleep, restored appetite, changed complexion.
  6. Decreased condensation: decreased medication of diuretic.”
Liver Cirrhosis Stem Cell Therapy

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Alzheimer’s disease: Intrathecal injection

“Before stem cell therapy:
  1. Failure of memory
  2. Disoriented time, place, person
  3. Walking difficulty, change in person’s characteristics and mood”
Alzheimers Disease Stem Cell Clinical Trials

Alzheimers Disease Stem Cell Therapy Clinical Trials

Osteoporosis

Osteoporosis Spine and Hip Regions


Crohn’s disease: I.V. injection

“Crohn’s disease is a severe self-immunity condition which results in removal of the pancreas, because this type of disease continuously attacks the pancreas – causing inflammation inside of patient’s body parts. In the case of Crohn’s disease, Stem Cell Therapy is provided through I.V in order for patients to improve the immune status and to maintain a normal immune system because it is impossible to inject stem cell to a specific part of disease directly.”
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Lou Gehrig’s disease (ALS): Intrathecal injection

  1. Patients are currently not progressing to tracheostomy & artificial ventilator.
  2. Muscular atrophy has slowed down, and muscle volume is maintained.
  3. All patients who received stem cell therapy have survived, while others without the therapy had died.

Cerebral infarction: Injection at brain directly or Intrathecal injection

  1. Case of cerebral hemorrhage: 2 patients treated
    “There was a patient who fell down the stairs in 2002, and incurred cerebral hemorrhage by head trauma and incomplete paraplegia, gait disturbance, equilibrium disturbance and speech disturbance. This patient hadn’t gotten any improvement before Stem Cell Therapy was applied to him, and after Stem Cell Therapy, the patient was able to walk by himself without any assistance and to pronounce clearly.”
  2. Case of cerebral infarction: 5 patients treated
    “After cerebral infarction occurrence in August, 2004, a patient couldn’t eat for having complete right side paraplegia and food aspiration, so the patient was fed only through a tube. After Stem Cell Therapy, the patient was able to walk 10 meters, and showed improvement of food aspiration leading the patient to self-eating food
  3. Difficulty in normal life and public relations
  4. Brain CT: multiple cerebral infarction, atrophy
  5. T-score: -4.2 (DSM-III-R basis: Status of serious illness disorder)
- After stem cell therapy
  1. Can read the time
  2. More stable during night times
  3. Can distinguish her grandchildren
  4. Sensible to cleanness and dirtiness
  5. Her insomnia has improved.
  6. Can memorize the apostolic creed quite well.

Baldness: 46 patients cured

  1. Efficacy details: Up to 20% growth of hair on scalp
  2. For more information, see our Hair Restoration page
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