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While researching about amniotic membrane eye drops (known on this forum as AMX or HAMT-EU drops), I wanted to share my findings. If anyone learns of clinical trials in the UK for this new method or any other way of obtaining them outside Italy then please let me know.
> English presentation by developer Dr. Emiliano Ghinelli (Youtube Video) <
Below I tried to translate some Italian articles. I don't know Italian, I used online tools, so I apologize for mistakes.
> English presentation by developer Dr. Emiliano Ghinelli (Youtube Video) <
Below I tried to translate some Italian articles. I don't know Italian, I used online tools, so I apologize for mistakes.
About HAMT-EU
Dr. Emiliano Ghinelli
Co-Author(s): : K. Kenyon L. Vedovelli A. Rodella R. Biasiolo
The National Institute of Health and the Ministry of Health have approved my technique based on the transplantation of elementary units of human amniotic membrane (HAMTEU).
In reality they're eye drops which contain elementary units of amniotic membrane which, in contact with the eye, release an effective mix of neurorigenerative substances, nutrients and anti-inflammatories able to repair neurotrophic corneal ulcers, block some pathologies and post corneal transplantation rejection.
Presented at the Athens 2016 ESCRS Meeting, HAMT-EU transplantation is an innovative, fast and convenient treatment for eye diseases. This way they avoid the risks linked to surgery and reduces recovery time. Compared to classic HAM transplant, this method is applicable to a larger number of patients with the possibility of longer periods of treatment even for chronic diseases.
What are HAMT-EU?
Elementary units of human amniotic membrane dispersed in an eye drop that replace traditional surgery. The elementary units are tiny frozen and freeze-dried elements that maintain macro and microscopic structure of the source human tissue. The amniotic membrane is processed according to the “Prime 21” lyophilization method that uses a planetary mill and precise working phases to obtain small AM fragments (400 squaremicrons area) that retain the original tissue ultrastructure (epithelium, basal membrane, and stroma). The resultant HAMT-EU are subsequently rehydrated, applied topically, and available for continuous use as the clinical situation warrants.
Where does the amniotic membrane come from?
The amniotic membrane used for HAMT-EU comes from the placentas of elective mothers undergoing cesarean delivery and, only after a careful history and serology, is collected from selected donors, prepared, preserved and transformed.
Results
In preliminary, open label applications for cases of persistent corneal epithelial defects of various etiologies, HAMT-EU retained the same properties of the cryopreserved/thawed membrane patch while adding the suture-less ease of use and the possibility of prolonged use. During clinical trials, no specific adverse side effects were observed.
HAMT-EU transplant differs from AM graft by the absence of sutures application and the easier preservation and delivery. The full biological identity of the original patch is preserved in a small scale and the advanced lyophilization process does not alter the bio-mechanical properties of the tissue. In the same way as the AM transplant, HAMTEU would support corneal protection and enhance corneal re-epithelialization. This new use of AM could change the management of several acute and chronic ocular surface diseases copping the rising request of intervention, avoiding hospitalization and stemming healthcare costs
Indication of Therapeutic Use
Dry eye, Blepharitis, Conjunctivitis, Keratitis, Corneal ulcers, Autoimmune diseases, Rejection of corneal, Foreign body sensation, Keratopathies exhibition.
Distribution
To ophthalmologists who request it the product is distributed by the Bank of Treviso Tissue: www.fbtv-treviso.org.
Financial Disclosure
One or more of the authors gains financially from product or procedure presented, One or more of the authors receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented. One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented.
Sources:
ESCRS Presentation Summary
Facebook Post by Dr. Emiliano Ghinelli
Dr. Emiliano Ghinelli
Co-Author(s): : K. Kenyon L. Vedovelli A. Rodella R. Biasiolo
The National Institute of Health and the Ministry of Health have approved my technique based on the transplantation of elementary units of human amniotic membrane (HAMTEU).
In reality they're eye drops which contain elementary units of amniotic membrane which, in contact with the eye, release an effective mix of neurorigenerative substances, nutrients and anti-inflammatories able to repair neurotrophic corneal ulcers, block some pathologies and post corneal transplantation rejection.
Presented at the Athens 2016 ESCRS Meeting, HAMT-EU transplantation is an innovative, fast and convenient treatment for eye diseases. This way they avoid the risks linked to surgery and reduces recovery time. Compared to classic HAM transplant, this method is applicable to a larger number of patients with the possibility of longer periods of treatment even for chronic diseases.
What are HAMT-EU?
Elementary units of human amniotic membrane dispersed in an eye drop that replace traditional surgery. The elementary units are tiny frozen and freeze-dried elements that maintain macro and microscopic structure of the source human tissue. The amniotic membrane is processed according to the “Prime 21” lyophilization method that uses a planetary mill and precise working phases to obtain small AM fragments (400 squaremicrons area) that retain the original tissue ultrastructure (epithelium, basal membrane, and stroma). The resultant HAMT-EU are subsequently rehydrated, applied topically, and available for continuous use as the clinical situation warrants.
Where does the amniotic membrane come from?
The amniotic membrane used for HAMT-EU comes from the placentas of elective mothers undergoing cesarean delivery and, only after a careful history and serology, is collected from selected donors, prepared, preserved and transformed.
Results
In preliminary, open label applications for cases of persistent corneal epithelial defects of various etiologies, HAMT-EU retained the same properties of the cryopreserved/thawed membrane patch while adding the suture-less ease of use and the possibility of prolonged use. During clinical trials, no specific adverse side effects were observed.
HAMT-EU transplant differs from AM graft by the absence of sutures application and the easier preservation and delivery. The full biological identity of the original patch is preserved in a small scale and the advanced lyophilization process does not alter the bio-mechanical properties of the tissue. In the same way as the AM transplant, HAMTEU would support corneal protection and enhance corneal re-epithelialization. This new use of AM could change the management of several acute and chronic ocular surface diseases copping the rising request of intervention, avoiding hospitalization and stemming healthcare costs
Indication of Therapeutic Use
Dry eye, Blepharitis, Conjunctivitis, Keratitis, Corneal ulcers, Autoimmune diseases, Rejection of corneal, Foreign body sensation, Keratopathies exhibition.
Distribution
To ophthalmologists who request it the product is distributed by the Bank of Treviso Tissue: www.fbtv-treviso.org.
Financial Disclosure
One or more of the authors gains financially from product or procedure presented, One or more of the authors receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented. One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented.
Sources:
ESCRS Presentation Summary
Facebook Post by Dr. Emiliano Ghinelli
A new liquid ocular transplant from Italy (September 9th, 2016)
The Italian Ministry of Health has recently approved the use of an innovative liquid transplant, devoid of surgery, for eye care. It's called "Human Amniotic Membrane Elemental Units" and was developed by Dr. Emiliano Ghinelli, ophthalmologist surgeon, specialist in ocular microsurgery and scientific director of ILMO (Institute of Laser Eye Microsurgery) in Brescia.
The revolutionary transplant is administered as simple eye drops, but despite the apparent banality it manages to block several eye diseases from the first signs of development, such as neurotrophic corneal ulcers, autoimmune diseases and rejection of corneal transplantation.
Interview with Dr. Emiliano Ghinelli
What is the transplantation of amniotic membrane elementary units?
With the liquid transplant the tissue used is reduced to very small particles that do not require surgery. It is an innovative technique born from the idea of treating some diseases before they become surgical. In other words I wanted to prevent these diseases from becoming chronic and I therefore decided to process human tissue capable of restoring the eye's physiological conditions before the damage escalates.
What was the actual path you took to realize the liquid transplant?
After the first experimental evidence obtained in the laboratory we tried this technique on animals, then on human cells in vitro, in the end we passed to clinical trials on a small number of patients. The Ministry of Health has therefore approved this process as a transplant.
And how was this idea born?
I had the intuition in Italy, I did the tests in the United States, and in the end I consolidated and re-engineered the technique in Italy.
In the United States I ran experiments on animals and human cells, but without the use of amniotic membrane extracts. In Italy, however, I could use a cocktail derived from amniotic membrane to achieve the healing of diseases that lead to a need for surgical intervention. In theory I knew that this compound would work, but I had no proof.
How will you proceed now? Is it already available to patients?
The next step will be to try to increase the number of transplants performed, currently zero. I only recently obtained ministerial approval so tissue banks are still gearing up and waiting for doctors to begin to order this transplant.
In the coming months it will be necessary to instruct colleagues on proper use so as to prevent it being stamped as inefficient without realizing its capabilities.
May this transplantation also be effective for other diseases?
The amniotic membrane is a tissue that has now been applied on the eye for 50 years via needle and thread. The transplantation of elementary units can 100 percent replace the traditional technique for ocular pathologies, but can also form the basis for treatment of other neurodegenerative diseases. The cocktail contained within the amniotic membrane is in fact a pool of growth factors that might be effective in many other diseases. Of course, it will take years of experiments and research. Suffice to say, I started to develop this new technique in 2001 and was approved only in 2016.
Why have approval times been so long?
The Italian state is very cautious in giving permissions within medicine, mainly to avoid unfounded gurus and healing expectations.
I still want to turn to my colleagues, for example, neurologists, dermatologists and orthopedic doctors, and tell them to roll up their sleeves to authorize this kind of transplantation for other diseases they treat. In my view, on the basis of the scientific literature, this could be beneficial to important diseases such as Alzheimer's, multiple sclerosis and Parkinson's.
Source:
News Article
The Italian Ministry of Health has recently approved the use of an innovative liquid transplant, devoid of surgery, for eye care. It's called "Human Amniotic Membrane Elemental Units" and was developed by Dr. Emiliano Ghinelli, ophthalmologist surgeon, specialist in ocular microsurgery and scientific director of ILMO (Institute of Laser Eye Microsurgery) in Brescia.
The revolutionary transplant is administered as simple eye drops, but despite the apparent banality it manages to block several eye diseases from the first signs of development, such as neurotrophic corneal ulcers, autoimmune diseases and rejection of corneal transplantation.
Interview with Dr. Emiliano Ghinelli
What is the transplantation of amniotic membrane elementary units?
With the liquid transplant the tissue used is reduced to very small particles that do not require surgery. It is an innovative technique born from the idea of treating some diseases before they become surgical. In other words I wanted to prevent these diseases from becoming chronic and I therefore decided to process human tissue capable of restoring the eye's physiological conditions before the damage escalates.
What was the actual path you took to realize the liquid transplant?
After the first experimental evidence obtained in the laboratory we tried this technique on animals, then on human cells in vitro, in the end we passed to clinical trials on a small number of patients. The Ministry of Health has therefore approved this process as a transplant.
And how was this idea born?
I had the intuition in Italy, I did the tests in the United States, and in the end I consolidated and re-engineered the technique in Italy.
In the United States I ran experiments on animals and human cells, but without the use of amniotic membrane extracts. In Italy, however, I could use a cocktail derived from amniotic membrane to achieve the healing of diseases that lead to a need for surgical intervention. In theory I knew that this compound would work, but I had no proof.
How will you proceed now? Is it already available to patients?
The next step will be to try to increase the number of transplants performed, currently zero. I only recently obtained ministerial approval so tissue banks are still gearing up and waiting for doctors to begin to order this transplant.
In the coming months it will be necessary to instruct colleagues on proper use so as to prevent it being stamped as inefficient without realizing its capabilities.
May this transplantation also be effective for other diseases?
The amniotic membrane is a tissue that has now been applied on the eye for 50 years via needle and thread. The transplantation of elementary units can 100 percent replace the traditional technique for ocular pathologies, but can also form the basis for treatment of other neurodegenerative diseases. The cocktail contained within the amniotic membrane is in fact a pool of growth factors that might be effective in many other diseases. Of course, it will take years of experiments and research. Suffice to say, I started to develop this new technique in 2001 and was approved only in 2016.
Why have approval times been so long?
The Italian state is very cautious in giving permissions within medicine, mainly to avoid unfounded gurus and healing expectations.
I still want to turn to my colleagues, for example, neurologists, dermatologists and orthopedic doctors, and tell them to roll up their sleeves to authorize this kind of transplantation for other diseases they treat. In my view, on the basis of the scientific literature, this could be beneficial to important diseases such as Alzheimer's, multiple sclerosis and Parkinson's.
Source:
News Article