{"id":996,"date":"2020-06-29T02:07:13","date_gmt":"2020-06-29T02:07:13","guid":{"rendered":"http:\/\/joshmitteldorf.peachpuff-wolverine-566518.hostingersite.com\/?p=996"},"modified":"2020-06-29T02:07:13","modified_gmt":"2020-06-29T02:07:13","slug":"human-trials-of-plasma-exchange","status":"publish","type":"post","link":"https:\/\/scienceblog.com\/joshmitteldorf\/2020\/06\/29\/human-trials-of-plasma-exchange\/","title":{"rendered":"Human Trials of Plasma Exchange"},"content":{"rendered":"

Animal experiments demonstrating the anti-aging effects of exchanging young blood plasma for old have been prominent in the last two months. Several groups are saying it’s time to translate their findings into human trials. But I\u2019ve recently learned that others have been doing this for several years. What can we learn from their results to guide the next steps in experimentation?<\/em><\/p>\n

\n

I had never heard of\u00a0Grifols<\/a>, the Spanish pharmaceutical company that is the world\u2019s largest supplier of albumin.\u00a0Since 2005<\/a>, Grifols has been quietly funding world leaders in plasma exchange research in humans.\u00a0Albutein<\/a>\u00ae is their brand-name solution of human albumin.<\/p>\n

Last month, the\u00a0first results<\/a>\u00a0of the Grifol\u2019s AMBAR trial were released. (AMBAR stands for\u00a0A<\/span>lzheimer\u2019s\u00a0M<\/span>odulation\u00a0B<\/span>y\u00a0A<\/span>lbumin\u00a0R<\/span>eplacement). It was a much larger-scale phase 2.5 trial, with 496 subjects recruited from sites in Spain and USA, and treated for 14 months. A single treatment consisted of removing 2.5 to 3 litres of blood (more than half the body\u2019s inventory) and replacing it with Albutein. Patients began with 6 weekly treatments, and thereafter there were 12 monthly smaller plasma replacements (0.7 litres), again with Albutein.<\/p>\n

Subjects were evaluated with two standard measures, one of cognitive ability and the other of ability to function independently. Most subjects got worse over the year, as AD is a progressive disease. But treated subjects progressed less than half as fast as sham-treated controls. There was enough variation among individuals that even this strong difference in averages was only marginally statistically significant.<\/p>\n

Subjects were categorized as \u201cmild\u201d to \u201cmoderate\u201d in their cognitive loss. \u201cModerate\u201d subjects responded a little better than \u201cmild\u201d, within statistical limits.<\/p>\n

In the Conboy paper which I recently reviewed, albumin was considered to be just a passive replacement of proteins that every mammal needs. Albumin was replaced in the blood because when harmful signaling proteins were diluted out of the blood, albumin was removed along with it. The body needs the albumin, while the protein signals were doing damage. Henced they replaced the albumin.<\/p>\n

But in AMBAR, albumin is considered an active part of the therapy.<\/p>\n

[P]lasma albumin from AD patients is more glycated and nitrotyrosinated than plasma from healthy subjects, reducing its ability to inhibit A\u03b2 aggregation Grifols theorized that replacing AD patients\u2019 albumin with therapeutic-grade albumin should overcome this problem. Further, therapeutic-grade albumin should more effectively bind plasma A\u03b2 and sequester it than plasma albumin from AD patients. Albumin may protect neurons by additional mechanisms, including anti-oxidant and anti-inflammatory activities.\u00a0 [review<\/a>, referencing\u00a0\u00a0this primary source<\/a>].<\/em><\/p><\/blockquote>\n

In one branch of the AMBAR program, \u00bc of subjects also received intravenous\u00a0immunoglobulin<\/a>\u00a0(IVIG). This consists of antibodies which identify challenges to which the immune system can respond. Grifols has a proprietary IG product called\u00a0Flebogamma<\/a>\u00ae. The AMBAR trial was unable to detect a benefit from IVIG.<\/p>\n

Plasma exchange has a\u00a0long history<\/a>\u00a0for treatment of auto-immune disorders. Some of the diseases of old age are related to autoimmunity (e.g., diabetes, arthritis, chronic inflammation).\u00a0Older persons have a higher generalized autoimmunity, but a lower incidence of explicitly autoimmune diseases<\/a>. Presumably, there are antibodies to self that accumulate in the bloodstream with age, and in recent years this has been\u00a0related to leaky gut<\/a>\u00a0disorders. It makes sense to me that blood dilution would be a downstream or stop-gap treatment for autoimmunity, but that better approaches would be directed at the source of the offending antibodies.<\/p>\n

<\/p>\n

Dobri Kiprov<\/a>\u00a0was a co-author of the Conboys\u2019\u00a0plasma dilution paper<\/a>. Kiprov\u2019s clinic has been a site in the AMBAR trials, with experience in plasma exchange\u00a0going back 20 years<\/a>. Kripov has\u00a0studied plasma exchange<\/a>\u00a0for a variety of diseases. In these treatments, a patient\u2019s blood is removed and separated. The patient\u2019s own red and white blood are returned to him, but his plasma is replace with saline, albumin, and possibly other ingredients. When I spoke to him, he described work which is soon to be published in\u00a0Alzheimer\u2019s and Dementia<\/a>\u00a0involving a proprietary added ingredient in these plasma transfusions. Benefits last at least 6 months, he said, which suggests that there is some epigenetic re-programming of the cellular sources of blood constituents.<\/p>\n

Kiprov\u00a0claims<\/a>\u00a0that patients who receive frozen blood plasma for a variety of reasons have fewer adverse reactions when they receive plasma from young donors (18-24) compared to middle-aged donors (35-45). He has seen patients\u2019 immune systems improve, and arthritis symptoms decrease. He\u2019s eager to see formal trials proceed for these conditions (but someone has to fund them).<\/p>\n

The bottom line<\/span><\/p>\n

As a treatment for AD, these results are not impressive. Patients were already quite disabled, and the results were essentially to prolong their end-of-life institutional existence. There are no effective drugs for AD, so compared to any pharmaceutical, AMBAR looks good. But compare these results to Bredesen\u2019s\u00a0RECODE program<\/a>, which aims to improve cognition, and in some cases has returned people to productivity from a non-functional state. RECODE works better the earlier you start it, whereas preliminary results suggests that AMBAR is more effective in late stages.<\/p>\n

Inflammation is a driver of all the diseases of old age. Pro-inflammatory signals (cytokines<\/a>) in the blood were among the elements diluted by AMBAR, and it may be that reduction in inflammation fully accounts for the program\u2019s successes.<\/p>\n

As a proof of principle, the results are quite informative. A benefit was demonstrated from plasma exchange in humans for the first time. Subjects did not become dramatically younger, despite much more dilution than in the Conboy mouse experiments (reviewed\u00a0in this space earlier this month<\/a>). They suggest that simple dilution as pioneered by the Conboys in mice might be effective in slowing senescence but not reducing biological age.<\/p>\n

\n

Two plasma exchange doctors were kind enough to help me with this column. I\u2019m grateful to\u00a0<\/span>David Haase<\/a>\u00a0(TX) and\u00a0<\/span>Dobri Kiprov<\/a>\u00a0(CA) for offering background and providing direction to my readings.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Animal experiments demonstrating the anti-aging effects of exchanging young blood plasma for old have been prominent in the last two months. Several groups are saying it’s time to translate their findings into human trials. But I\u2019ve recently learned that others have been doing this for several years. What can we learn from their results to … Read more<\/a><\/p>\n","protected":false},"author":65,"featured_media":997,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-996","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nHuman Trials of Plasma Exchange - Josh Mitteldorf<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/scienceblog.com\/joshmitteldorf\/2020\/06\/29\/human-trials-of-plasma-exchange\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human Trials of Plasma Exchange\" \/>\n<meta property=\"og:description\" content=\"Animal experiments demonstrating the anti-aging effects of exchanging young blood plasma for old have been prominent in the last two months. 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The surprising fact that our bodies are genetically programmed to age and to die offers an enormous opportunity for medical intervention. It may be that therapies to slow the progress of aging need not repair or regenerate anything, but only need to interfere with an existing program of self-destruction. Mitteldorf has taught a weekly yoga class for thirty years. He is an advocate for vigorous self care, including exercise, meditation and caloric restriction. After earning a PhD in astrophysicist, Mitteldorf moved to evolutionary biology as a primary field in 1996. He has taught at Harvard, Berkeley, Bryn Mawr, LaSalle and Temple University. He is presently affiliated with MIT as a visiting scholar. In private life, Mitteldorf is an advocate for election integrity as well as public health. He is an avid amateur musician, playing piano in chamber groups, French horn in community orchestras. His two daughters are among the first children adopted from China in the mid-1980s. Much to the surprise of evolutionary biologists, genetic experiments indicate that aging has been selected as an adaptation for its own sake. This poses a conundrum: the impact of aging on individual fitness is wholly negative, so aging must be regarded as a kind of evolutionary altruism. Unlike other forms of evolutionary altruism, aging offers benefits to the community that are weak, and not well focussed on near kin of the altruist. 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The surprising fact that our bodies are genetically programmed to age and to die offers an enormous opportunity for medical intervention. It may be that therapies to slow the progress of aging need not repair or regenerate anything, but only need to interfere with an existing program of self-destruction. Mitteldorf has taught a weekly yoga class for thirty years. He is an advocate for vigorous self care, including exercise, meditation and caloric restriction. After earning a PhD in astrophysicist, Mitteldorf moved to evolutionary biology as a primary field in 1996. He has taught at Harvard, Berkeley, Bryn Mawr, LaSalle and Temple University. He is presently affiliated with MIT as a visiting scholar. In private life, Mitteldorf is an advocate for election integrity as well as public health. He is an avid amateur musician, playing piano in chamber groups, French horn in community orchestras. His two daughters are among the first children adopted from China in the mid-1980s. Much to the surprise of evolutionary biologists, genetic experiments indicate that aging has been selected as an adaptation for its own sake. This poses a conundrum: the impact of aging on individual fitness is wholly negative, so aging must be regarded as a kind of evolutionary altruism. Unlike other forms of evolutionary altruism, aging offers benefits to the community that are weak, and not well focussed on near kin of the altruist. This makes the mechanism challenging to understand and to model. more at http:\/\/mathforum.org\/~josh","sameAs":["http:\/\/AgingAdvice.org"],"url":"https:\/\/scienceblog.com\/joshmitteldorf\/author\/joshmitteldorf\/"}]}},"jetpack_featured_media_url":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-content\/uploads\/sites\/2\/2020\/06\/tpe.png","jetpack_shortlink":"https:\/\/wp.me\/pgtN8h-g4","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/posts\/996","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/users\/65"}],"replies":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/comments?post=996"}],"version-history":[{"count":0,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/posts\/996\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/media\/997"}],"wp:attachment":[{"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/media?parent=996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/categories?post=996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scienceblog.com\/joshmitteldorf\/wp-json\/wp\/v2\/tags?post=996"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}