Histogen Hair Loss Treatment Update From Dr. Gail Naughton
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New funding: 03/17/2017
Histogen Awarded $750k funding.
Start Date: 03/15/2017
End Date: 02/28/2019
Award Title or Description: STTR Phase II: A novel wound dressing for infection control and tissue regeneration.
Most recent abstract submitted for the grant:
The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is to overcome limitations that prevent effective treatment of wound infections. There is a large potential market for this product as the U.S. spends over $50 billion per year on wound care and current wound care products have a high risk of rejection, scarring, and antibiotic resistance. The proposed novel wound care product will reduce the costs to treat infected wounds and limit the number of medical procedures required to restore tissue function. The product consists of a patented human extracellular matrix (hECM) coupled to a novel antimicrobial peptide (AMP). The main innovation of the proposed product, compared to current treatments, is that it is designed to be toxic to infective bacteria and other pathogens, without harming human tissue. The hECM has regenerative and anti-inflammatory activity to enhance wound healing and improve treatment outcomes. In addition to creating a transformative product in a global market, achievement of AMP extracellular matrix tethering will lead to a broader understanding of AMP activity and unlock their commercial utility. The product can be used as a temporary wound dressing, a tissue restoring implant, or an implant coating. The proposed project will utilize a patented recombinant protein with an antimicrobial peptide, combined with a human extracellular matrix (hECM) material. The patented antimicrobial protein (AMP) is designed to bind collagen in the hECM. The combination of hECM and AMP will result in an antimicrobial regenerative matrix that will reduce the incidence of infection and improve wound healing. The objectives of the project are to scale-up hECM and AMP manufacturing processes, establish methods for assessing product characteristics and performance for manufacturing quality assurance and release criteria, and evaluate the shelf-life and in vivo performance of the scaled-up manufactured AMP-hECM product in a clinically relevant infectious wound healing model. The AMP-hECM will be evaluated using biochemical, antimicrobial, mechanical and cell growth performance assays. Scale-up of the bioengineered AMP and hECM will be achieved by optimizing the in vitro manufacturing bioreactor growth parameters and processing methods to improve overall product yield. The anticipated outcome of the project is to have defined the large-scale manufacturing protocols and release criteria for the AMP-hECM product. This milestone will enable the execution of validation production runs, and advance the regulatory and commercialization pathways for the product.
Source: research.gov
Posted yesterday so seems like there is some progress going on. Clueless as to what the abstract means if it is even worth anything new.
Histogen Awarded $750k funding.
Start Date: 03/15/2017
End Date: 02/28/2019
Award Title or Description: STTR Phase II: A novel wound dressing for infection control and tissue regeneration.
Most recent abstract submitted for the grant:
The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is to overcome limitations that prevent effective treatment of wound infections. There is a large potential market for this product as the U.S. spends over $50 billion per year on wound care and current wound care products have a high risk of rejection, scarring, and antibiotic resistance. The proposed novel wound care product will reduce the costs to treat infected wounds and limit the number of medical procedures required to restore tissue function. The product consists of a patented human extracellular matrix (hECM) coupled to a novel antimicrobial peptide (AMP). The main innovation of the proposed product, compared to current treatments, is that it is designed to be toxic to infective bacteria and other pathogens, without harming human tissue. The hECM has regenerative and anti-inflammatory activity to enhance wound healing and improve treatment outcomes. In addition to creating a transformative product in a global market, achievement of AMP extracellular matrix tethering will lead to a broader understanding of AMP activity and unlock their commercial utility. The product can be used as a temporary wound dressing, a tissue restoring implant, or an implant coating. The proposed project will utilize a patented recombinant protein with an antimicrobial peptide, combined with a human extracellular matrix (hECM) material. The patented antimicrobial protein (AMP) is designed to bind collagen in the hECM. The combination of hECM and AMP will result in an antimicrobial regenerative matrix that will reduce the incidence of infection and improve wound healing. The objectives of the project are to scale-up hECM and AMP manufacturing processes, establish methods for assessing product characteristics and performance for manufacturing quality assurance and release criteria, and evaluate the shelf-life and in vivo performance of the scaled-up manufactured AMP-hECM product in a clinically relevant infectious wound healing model. The AMP-hECM will be evaluated using biochemical, antimicrobial, mechanical and cell growth performance assays. Scale-up of the bioengineered AMP and hECM will be achieved by optimizing the in vitro manufacturing bioreactor growth parameters and processing methods to improve overall product yield. The anticipated outcome of the project is to have defined the large-scale manufacturing protocols and release criteria for the AMP-hECM product. This milestone will enable the execution of validation production runs, and advance the regulatory and commercialization pathways for the product.
Source: research.gov
Posted yesterday so seems like there is some progress going on. Clueless as to what the abstract means if it is even worth anything new.
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They're producing an injectible that will keep wounds free from infections. Basically it binds an antibacterial under the skin with an extracellular matrix. Think of it as an antibacterial injected into you that stays roughly in the area of the injection instead of spreading out all over the body.
It is also optimizing manufacturing of their antibacterial product and extracellular matrix product for commercial production. They will use this optimization to provide a protocol that manufacturers can follow to produce their antibacterial product and extracellular matrix product cheaply, quickly, and with high quality.
The only part that is relevant to hair loss is this will lead to better mass production of their ecm(extracellular matrix), which is necessary for their hair loss product called "HSC".
It is also optimizing manufacturing of their antibacterial product and extracellular matrix product for commercial production. They will use this optimization to provide a protocol that manufacturers can follow to produce their antibacterial product and extracellular matrix product cheaply, quickly, and with high quality.
The only part that is relevant to hair loss is this will lead to better mass production of their ecm(extracellular matrix), which is necessary for their hair loss product called "HSC".
Can someone explain to me when Histogens first trial in the US under clinicals.gov is still listed as unknown?
I mean I know they have their website and plenty of other sites reported on the study but it just seems disheartening that they didn't feel like turning in their results to clinicals....
I mean I know they have their website and plenty of other sites reported on the study but it just seems disheartening that they didn't feel like turning in their results to clinicals....
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I forgot the user's name, but I remember someone posted a screen shot of Gail saying that he should check with her in April. I hope the user is able to get in touch with her again, and that we hear from her soon!
I think that ship has sailed. Apparently they still haven't been able to find a partner in Mexico. At least they are well under way in China. China isn't such an easy trip for us Americans though for a treatment that is better with repeat visits.
They announced they had a partner, I think now they're both (histogen and partner) are dealing/meeting with COFPRIS (Mexican FDA) to get thing s moving. I mean they haven't announced the start of their next trial but they said it would be this summer and they still need the governing body's approval. Probably why they asked us to check back in April..... I friggin hope so at least
I know they said they were in negotiations for a partnership, but they never announced that they finalized a deal unless I missed it? I'm assuming the negotiations hit a dead end.
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That's true. I remember that post here too.
Can somebody provide me the e-mail address from Gail? Or try to contact them again?
Probably is not going to do much for our peace of mind, but at least we can give it a shoot.
Didn't they say the same thing last June? I can't keep up anymore, it's always same sh*t different year.
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- 540
https://www.benzinga.com/pressrelea...ytechnic-institute-receive-phase-ii-nsf-award
no hair related news but it's good to see they are not dead atleast. I wish they provided some update about their HSC product.
no hair related news but it's good to see they are not dead atleast. I wish they provided some update about their HSC product.