{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T12:34:48Z","timestamp":1789475688634,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T00:00:00Z","timestamp":1760227200000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The management of diabetic foot ulcers in patients with peripheral artery disease remains challenging. Human placenta\u2010derived cells (PDA\u2010002), a mesenchymal stromal cell\u2010like population obtained from full\u2010term placental tissue, possess angiogenic and tissue regenerative properties. Participants were stratified based on peripheral artery disease status. A total of 159 individuals were randomly assigned to receive intramuscular PDA\u2010002 at one of three doses (3\u2009\u00d7\u200910\n                    <jats:sup>6<\/jats:sup>\n                    , 10\u2009\u00d7\u200910\n                    <jats:sup>6<\/jats:sup>\n                    and 30\u2009\u00d7\u200910\n                    <jats:sup>6<\/jats:sup>\n                    cells) or a placebo. This Phase 2 multi\u2010center, randomised, double\u2010blind, placebo\u2010controlled trial evaluated adults with chronic diabetic foot ulcers with and without peripheral artery disease. The primary efficacy endpoint was the proportion of participants achieving complete wound closure of the index ulcer within 3\u2009months, with sustained closure maintained for an additional 4\u2009weeks. PDA\u2010002 was well\u2010tolerated, with no treatment\u2010related serious adverse events. Intramuscular PDA\u2010002 treatment achieved the highest efficacy at the 3\u2009\u00d7\u200910\n                    <jats:sup>6<\/jats:sup>\n                    cell dose within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4\u2010week durability endpoint that surpassed the U.S. Food and Drug Administration's recommended 2\u2010week sustainability criterion. PDA\u2010002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re\u2010treatment.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    identifier: NCT # 02264288\n                  <\/jats:p>","DOI":"10.1111\/iwj.70769","type":"journal-article","created":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T02:29:41Z","timestamp":1760322581000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Human Placenta\u2010Derived Cells (\n                    <scp>PDA<\/scp>\n                    \u2010002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi\u2010Center, Randomised, Double\u2010Blind, Placebo\u2010Controlled Trial"],"prefix":"10.1111","volume":"22","author":[{"given":"Richard","family":"Pollak","sequence":"first","affiliation":[{"name":"Endeavor Clinical Trials PA  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Anderson","sequence":"additional","affiliation":[{"name":"Gateway Clinical Trials and Podiatry 1st  O'Fallon Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bert","family":"Altmanshofer","sequence":"additional","affiliation":[{"name":"Bert J Altmanshofer DMP and Associates  Duncansville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Caporusso","sequence":"additional","affiliation":[{"name":"Futuro Clinical Trials  McAllen Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Fantini","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1993-806X","authenticated-orcid":false,"given":"Sharmila","family":"Koppisetti","sequence":"additional","affiliation":[{"name":"Celularity Inc.  Florham Park New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Brigido","sequence":"additional","affiliation":[{"name":"Celularity Inc.  Florham Park New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Hariri","sequence":"additional","affiliation":[{"name":"Celularity Inc.  Florham Park New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,12]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.08.244"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-78215-7"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2013.02.014"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2174\/1573399816999201001203111"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dci22-0043"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.10578"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.13540"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2176"},{"issue":"7","key":"e_1_2_11_10_1","article-title":"Stem Cell\u2010Based Therapy: A Promising Treatment for Diabetic Foot Ulcer","volume":"10","author":"El Hage R.","year":"2022","journal-title":"Biomedicine"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13287-022-03110-9"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2023.1099310"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.3389\/fbioe.2023.1158484"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.5966\/sctm.2014-0135"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/cti.2014.5"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.04.387"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12715"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/193229681300700508"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xkme.2019.11.001"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13098-024-01291-2"},{"key":"e_1_2_11_21_1","unstructured":"FDA \u201cGuidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds\u2010Developing Products for Treatment \u201d(2006) Clinical\/Medical https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/chronic\u2010cutaneous\u2010ulcer\u2010and\u2010burn\u2010wounds\u2010developing\u2010products\u2010treatment."},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.semvascsurg.2023.04.012"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-008-0940-0"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13287-024-03713-4"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13287-020-02131-6"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000124062.31102.57"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm0405-367"}],"container-title":["International Wound Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.70769","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T02:31:58Z","timestamp":1768185118000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iwj.70769"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":26,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1111\/iwj.70769"],"URL":"https:\/\/doi.org\/10.1111\/iwj.70769","archive":["Portico"],"relation":{},"ISSN":["1742-4801","1742-481X"],"issn-type":[{"value":"1742-4801","type":"print"},{"value":"1742-481X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"2025-03-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-06","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70769"}}