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allogeneic hematopoietic stem cells

Trade name: Hemacord

Cell therapyapproved

Approved

Nov 10, 2011

Clinical trial activity

405 trials · 228 clinical orgs · 8 marketing orgs

Phase 1
101
Phase 2
290
Phase 3
53
Phase 4
1

Earliest trial started May 1, 1986 (NCT00002456)

Timeline

1980s

  1. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1987

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jan 1, 1994

    University of Texas at Houston — Earliest Phase 1 Sponsor(trial)

2010s

  1. Nov 10, 2011

    New York Blood Center — Earliest FDA Approval

  2. Nov 10, 2011

    New York Blood Center — NDA Organization

  3. May 24, 2012

    Clinimmune Labs — NDA Secondary Org

  4. Oct 4, 2012

    Duke University — NDA Secondary Org

  5. May 30, 2013

    St. Louis University — NDA Secondary Org

  6. Jun 13, 2013

    LifeSouth Community Blood Centers, Inc. — NDA Secondary Org

  7. Jan 28, 2016

    Bloodworks Northwest — NDA Secondary Org

  8. Sep 1, 2016

    Cleveland Cord Blood Center — NDA Secondary Org

  9. Jun 21, 2018

    University of Texas at Houston — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 10, 2011

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Also known as

  • allogeneic adult mesenchymal bone marrow stem cells
  • allogeneic bone marrow
  • allogeneic bone-marrow derived adult mesenchymal stem cell
  • allogeneic bone marrow-derived human mesenchymal stem cells
  • allogeneic bone marrow derived mesenchymal stem cells
  • allogeneic hematopoietic cell
  • allogeneic hematopoietic stem cell
  • allogeneic hematopoietic stem cells
  • allogeneic mesenchymal bone marrow cells
  • allogenic bone marrow derived mesenchymal stem cell
  • allogenic bone marrow derived mesenchymal stem cells
  • autologous-allogeneic tandem hematopoietic stem cell
  • autologous bone-marrow derived adult mesenchymal stem cell
  • bone marrow mesenchimal stem cells
  • bone marrow mesenchymal stem cells
  • cbma
  • donor haematopoietic stem cell
  • donor hematopoietic stem cell
  • donor hematopoietic stem cells
  • ex vivo cultured adult allogenic mesenchymal stem cells
  • hemacord
  • hematopoietic progenitor cell
  • hematopoietic progenitor cells
  • hematopoietic progenitor cells, cord (hpc-c), cord blood
  • hlcm051
  • human stem cell
  • umbilical cord blood hematopoietic stem cell

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07157514Phase 2/Phase 3 (Phase 3)Jan 31, 2026Actinium Pharmaceuticals
NCT07269041Phase 1/Phase 2 (Phase 2)Jan 31, 2026University of California, Los Angeles
NCT07259161Phase 2Dec 15, 2025China Academy of Chinese Medical Sciences
NCT07284641Phase 2Dec 10, 2025University of Pittsburgh
NCT07117305Phase 1/Phase 2 (Phase 2)Sep 1, 2025Government of China, Zhengzhou University
NCT07108530Phase 2Aug 6, 2025Shanxi Bethune Hospital
NCT07059156Phase 2/Phase 3 (Phase 3)Jun 1, 2025Shanxi Bethune Hospital
NCT06996392Phase 1May 7, 2025Sun Yat-Sen University
NCT06643195N/AJan 1, 2025China Academy of Chinese Medical Sciences
NCT06646497Phase 2Nov 1, 2024Assistance Publique - Hôpitaux de Paris
NCT06633328Early Phase 1 (Phase 1)Oct 20, 2024Yake Biotechnology Ltd., Zhejiang University
NCT06893250Phase 2/Phase 3 (Phase 3)Sep 23, 2024University Hospital of North Norway
NCT06516679Phase 2Aug 31, 2024Yonsei University
NCT06235398Phase 2Feb 1, 2024Assistance Publique - Hôpitaux de Paris
NCT06149403Phase 3Dec 31, 2023Orchard Therapeutics Limited
NCT06727721Phase 2Nov 6, 2023Changhai Hospital
NCT06074783Phase 1/Phase 2 (Phase 2)Oct 31, 2023Cellcolabs Clinical LTD.
NCT06147505Phase 1/Phase 2 (Phase 2)Oct 29, 2023Soochow University
NCT05900401Phase 1/Phase 2 (Phase 2)Oct 1, 2023Harvard University, ITB-Med LLC, Ossium Health, Inc.
NCT05973734Phase 1Oct 1, 2023Stanford University, University of California, San Francisco
Showing 20 of 405 trials
Page 1 / 21

Organizations

Research & Development (228)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government1932641987
University of WashingtonAcademic/Hospital737241986
National Heart, Lung, and Blood Institute (NHLBI)Government27241995
City of Hope National Medical CenterAcademic/Hospital191631995
Stanford UniversityAcademic/Hospital141022004
University of MinnesotaAcademic/Hospital141231996
Northwestern UniversityAcademic/Hospital121141999
Cornell UniversityAcademic/Hospital111131992
University of California, San FranciscoAcademic/Hospital111031999
Johns Hopkins UniversityAcademic/Hospital101031995
Southwest Oncology GroupAcademic/Hospital9721994
Thomas Jefferson UniversityAcademic/Hospital9932010
European Organisation for Research and Treatment of CancerAcademic/Hospital8821993
Harvard UniversityAcademic/Hospital8441994
University of Texas at HoustonAcademic/Hospital7531994
Institut Paoli-CalmettesAcademic/Hospital6522002
St. Jude Children's HospitalAcademic/Hospital6522004
Sun Yat-Sen UniversityAcademic/Hospital6522010
Wayne State UniversityAcademic/Hospital6521987
Assistance Publique - Hôpitaux de ParisAcademic/Hospital5512021
228 organizations
Page 1 / 12

Marketing (8)

OrganizationOrg typeRelationshipDate
Bloodworks NorthwestAcademic/HospitalNDA2Jan 28, 2016
Cleveland Cord Blood CenterAcademic/HospitalNDA2Sep 1, 2016
Clinimmune LabsFor profitNDA2May 24, 2012
Duke UniversityAcademic/HospitalNDA2Oct 4, 2012
LifeSouth Community Blood Centers, Inc.Academic/HospitalNDA2Jun 13, 2013
New York Blood CenterAcademic/HospitalNDANov 10, 2011
St. Louis UniversityAcademic/HospitalNDA2May 30, 2013
University of Texas at HoustonAcademic/HospitalNDA2Jun 21, 2018