{"id":1533,"date":"2017-09-22T15:12:01","date_gmt":"2017-09-22T15:12:01","guid":{"rendered":"https:\/\/www.mc.vanderbilt.edu\/vanderbiltmedicine\/?p=1533"},"modified":"2021-08-11T19:39:29","modified_gmt":"2021-08-11T19:39:29","slug":"the-sanford-project","status":"publish","type":"post","link":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/the-sanford-project\/","title":{"rendered":"The Sanford Project"},"content":{"rendered":"
\n
\n
\n

Sanford Health, in collaboration with Caladrius Biosciences, Inc., is investigating whether a child’s own cells can fight type 1 diabetes. This clinical trial, known as The Sanford Project: T-Rex Study, studies an innovative investigational therapy in children newly diagnosed with type 1 diabetes. Vanderbilt is one of 15 sites participating in the trial.<\/p>\n

Researchers focus specifically on children’s Treg cells, which may help stop the immune system’s attack on the body’s insulin-producing beta cells. The Treg cells will be collected from the participants’ blood, grown in a lab to make more of them, and returned back into their blood circulation.<\/p>\n<\/div>\n<\/div>\n

\n
\n

Immune System Balance<\/h4>\n

Researchers are testing whether these expanded Treg cells can rebalance the immune system and stop the attack on beta cells.<\/p>\n<\/div>\n

\"Graphic\"<\/div>\n
\"Graphic\"<\/div>\n
\"Graphic\"<\/div>\n<\/div>\n
\n
\n

Four Steps to More Tregs<\/h4>\n

Treg cells are harvested from a study participant\u2019s blood, then multiplied in a laboratory to create an investigational treatment called CLBS03. The CLBS03 is then given back to the same patient intravenously.<\/p>\n<\/div>\n

\n
STEP 1<\/h5>\n

Blood is taken from the patient<\/p>\n

\"Graphic\"<\/p>\n<\/div>\n

\n
STEP 2<\/h5>\n

Treg cells are separated from blood<\/p>\n

\"Graphic\"<\/p>\n<\/div>\n

\n
STEP 3<\/h5>\n

In a lab, Treg cells are grown to make more Treg cells<\/p>\n

\"Graphic\"<\/p>\n<\/div>\n

\n
STEP 4<\/h5>\n

New Treg cells are returned to the patient<\/p>\n

\"Graphic\"<\/p>\n<\/div>\n<\/div>\n

\n
\n

Trial Design<\/h4>\n

This trial is the first for this therapy in the United States to enroll adolescents. To enroll, participants must be at a minimum 8-17 years old and have been diagnosed with diabetes in approximately the last two months.<\/p>\n<\/div>\n

\n

\"Graphic\"<\/p>\n

A randomized, placebo-controlled, double-blind Phase 2 trial<\/p>\n<\/div>\n

\n

\"Graphic\"<\/p>\n

Includes more than 100 children across 15 sites in the United States<\/p>\n<\/div>\n

\n

\"Graphic\"<\/p>\n

Could take two years or more to complete<\/p>\n<\/div>\n<\/div>\n

\n
\n

Timeline for Trial<\/h4>\n

[dyk-carousel-summer-2017]<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Sanford Health, in collaboration with Caladrius Biosciences, Inc., is investigating whether a child’s own cells can fight type 1 diabetes. This clinical trial, known as The Sanford Project: T-Rex Study, studies an innovative investigational therapy in children newly diagnosed with type 1 diabetes. Vanderbilt is one of 15 sites participating in the trial. Researchers focus…<\/p>\n","protected":false},"author":229,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"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":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_links_to":"","_links_to_target":""},"categories":[12,25],"tags":[],"class_list":["post-1533","post","type-post","status-publish","format-standard","hentry","category-vm-did-you-know","category-vm-summer-2017"],"acf":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pcDnub-oJ","_links":{"self":[{"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/posts\/1533","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/users\/229"}],"replies":[{"embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/comments?post=1533"}],"version-history":[{"count":1,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/posts\/1533\/revisions"}],"predecessor-version":[{"id":3052,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/posts\/1533\/revisions\/3052"}],"wp:attachment":[{"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/media?parent=1533"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/categories?post=1533"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medschool.vanderbilt.edu\/vanderbilt-medicine\/wp-json\/wp\/v2\/tags?post=1533"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}