A clinical trial of ALS patients conducted by BrainStorm Cell Therapeutics shows its adult stem cell therapy is well-tolerated, appears to be safe and does not present undue risk, according to an interim safety review.
Moreover, in some patients signs of stabilization of the disease were detected.
Israel-based BrainStorm is developing NurOwn for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
"It's very uncommon to give at such an early point in a clinical study efficacy data, but we cannot ignore the fact on an individual basis we could see improvement in many of the patients involved, each one in different areas," Moshe Neuman, CEO of Biomedical Research Design, which serves as a contract research organization for the trial, said.
In some patients breathing improved, in others it was muscle strength and in others it was speech, he told Reuters.
Neuman said a final report was expected by the end of the year after each patient has been observed for nine months.
BrainStorm President Chaim Lebovits said the preliminary results demonstrate that the stem cells have the potential not only to stop deterioration but perhaps even cure ALS.
"The coming phases in the trial will have to prove this, but these results also reaffirm our belief that we have an enormous potential of being successful with less severe indications such as multiple sclerosis and Parkinson's," he said.
Patients in the trial were transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology.
The Phase I/II trial, designed to evaluate the safety and preliminary efficacy of BrainStorm's therapy, is being conducted at Jerusalem's Hadassah Medical Center. The company submitted the interim safety report to Israel's Health Ministry.
"This important safety and tolerability data are reassuring as we progress to the next half of this trial," said Dimitrios Karussis of the Neurology Department at Hadassah, who is leading the trial. "Although this is an interim safety summary report documenting achievement of the study's primary endpoint, we cannot ignore some possible promising indications of clinical efficacy observed in single patients."
In one patient in particular, Rabbi Rafael Shmuelevitz of Jerusalem, significant improvement was seen. Shmuelevitz, who in addition to ALS also has a neuromuscular disease called myasthenia gravis, was received as a compassionate patient and given a higher dose than other patients.
In a letter to BrainStorm, a copy of which was obtained by Reuters, the rabbi said the treatment raised him "up from the depths and I have become like a new man."
Before the treatment he suffered from disequilibrium and could not walk without help from both sides, he said.
"Today, after the stem cell treatment, I am able to walk consistently and with stability even without the help of a cane. In my voice there is also immense improvement," he said.
BrainStorm is awaiting U.S. Food and Drug Administration approval to begin ALS trials at the University of Massachusetts Medical School and Massachusetts General Hospital.
"The next steps are to explore additional dosages and a Phase II safety and preliminary efficacy study that we plan to assist in designing," Merit Cudkowicz, chair of the neurological department at Massachusetts General Hospital, said.
According to the ALS Association, 5,600 people in the United States are diagnosed each year with the disease, which has severely disabled British physicist Stephen Hawking.
The FDA last year granted NurOwn orphan drug designation, which encourages the development of treatments for rare diseases by providing financial incentives.
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ReplyDelete(1) CANCER,
(2) DIABETES,
(3) ALS,
(4) URINARY TRACT INFECTION,
(5) CANCER,
(6) IMPOTENCE,
(7) BARENESS/INFERTILITY
(8) DIARRHEA
(9) ASTHMA...
10) HE ALSO HAVE SPELL TO BRING BACK YOUR EX
please i want every one with this virus to be free and be cured, that is why am dropping his email address. dr.eghonsherbalisttemple@hotmail.com do not hesitate to email him, he is a great man. the government is also interested in you DR EGhons thank you for saving my life, and I promise I will always and forever testify for your good work.
This is real take it serious, my name is Philip Davidson, i am from New York,who will believe that herbs can cure hiv&aids i never believe that this will work i have spend a lot when getting drugs from the hospital to keep me healthy, what i was waiting for is death because i was broke,one day i hard about this great man who is well know of HIV and cancer cure, i decided to email him,unknowingly to me that this will be the end of the hiv&aids in my body, he prepare the herbs for me and send it through courier service, and give me instruction on how to take it, at the end of the one month, he told me to go to the hospital for a check up, and i went,surprisingly after the test the doctor confirm me negative, i thought it was a joke, i went to other hospital was also negative, then i took my friend who was also suffering from hiv&aids to the herbal doctor, his name is Dr.EGHONS after the she has taking his herbs she was also confirm hiv&aids free . He also have the herb to cure.
ReplyDelete(1) CANCER,
(2) DIABETES,
(3) ALS,
(4) URINARY TRACT INFECTION,
(5) CANCER,
(6) IMPOTENCE,
(7) BARENESS/INFERTILITY
(8) DIARRHEA
(9) ASTHMA...
10) HE ALSO HAVE SPELL TO BRING BACK YOUR EX
please i want every one with this virus to be free and be cured, that is why am dropping his email address. dr.eghonsherbalisttemple@hotmail.com do not hesitate to email him, he is a great man. the government is also interested in you DR EGhons thank you for saving my life, and I promise I will always and forever testify for your good work.
All thanks to Dr Aba, I am here to share a life testimony of my self on how i came in contact with a real herbalist who helped me. i appreciate everyone for taken their precious time to read my testimony, 6 months ago i was diagnosed with ALS, this means that 6 months ago i was ALS positive when i told one of my good friend about this, she sympathized with me and then she said that she was going to help me out, she told me that we should do some research on the Internet, we came across Dr Aba and my friend said that she has come across a lot about him and said that he is a real herbalist remedy to all illness, i was really surprised on this and confused as well, I was so speechless and quickly i contact him to help me and he prepared some herbs for me and send it across to me and he told me the way i was going to be taken the medicine which i did, and in the next 2 weeks i went to the hospital and they said that i am now ALS negative, i am very happy about this, then i contacted Dr Aba again to tell him the good result , i asked him how he was able to help me, and he said that he was gifted with it that he can cure any disease. also reach him because health is better than wealth Email him via"dr.abaherbalhome@gmail.com you can call or whatsApp his number on +2348107155060 see more at drabaherbalhome.webs.com
ReplyDeleteGod bless Prophet suleman for his marvelous work in my life, I was diagnosed of ALS since 2012 and I was taking my medications, I wasn't satisfied i needed to get the ALS out of my system, I searched about some possible cure for ALS i saw a comment about Prophet suleman , how he cured ALS with his herbal medicine, I contacted him and he guided me. I asked for solutions, he started the remedy for my health, he sent me the medicine through UPS SPEED POST. I took the medicine as prescribed by him and 14 days later i was cured from ALS ,thank you prophetsuleman@gmail.com
ReplyDeleteI was checking for solution in the internet then miraculously came across Dr Ekpiku the powerful herbalist that cure numerous individuals HSV-1 AND HSV-2 INFECTION,then i contacted his email: ekpikuspellhomeofgrace@gmail.com i explained everything to him and prepared a cure that cure my HSV-1 AND HSV-2 disease totally after receiving his herbal medicine, so my friends viewers why wait and be suffer when there is someone like Dr Ekpiku that can cure any disease HIV/ CANCER/ HEPATITIS B VIRUS, you can contact his via: ekpikuspellhomeofgrace@hotmail.com or whatapps, call +2348073673757.
ReplyDelete