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bone marrow derived mesenchymal stem cells

Trade name: Ryoncil

Cell therapyapprovedOrphan Drug FDA

Approved

Dec 18, 2024

Bone marrow is a semi-solid tissue found within the spongy portions of bones. In birds and mammals, bone marrow is the primary site of new blood cell production. It is composed of hematopoietic cells, marrow adipose tissue, and supportive stromal cells. In adult humans, bone marrow is primarily located in the ribs, vertebrae, sternum, and bones of the pelvis. Bone marrow comprises approximately 5% of total body mass in healthy adult humans, such that a person weighing 73 kg (161 lbs) will have around 3.7 kg (8 lbs) of bone marrow. — Wikipedia

Clinical trial activity

172 trials · 226 clinical orgs · 1 marketing orgs

Phase 1
85
Phase 2
107
Phase 3
22
Phase 4
4

Earliest trial started Jul 1, 1999 (NCT00186914)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Dec 14, 2005

    Orphan Drug Designation

2020s

  1. Dec 18, 2024

    Mesoblast, Inc. — Earliest FDA Approval

  2. Dec 18, 2024

    Mesoblast, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetTissue restoration

    tissue restoration

Approval history

  • approvedDec 18, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • autologous alveolar bone-marrow derived mesenchymal stem cells
  • autologous alveolar bone marrow mesenchymal stem cells
  • autologous mesenchymal bone marrow cell
  • bone marrow autologous mesenchymal stem cells
  • bone marrow autologous stem cells
  • bone marrow derived mesenchymal stem cells
  • bone marrow-derived mesenchymal stem cells
  • bone marrow-derived progenitor cells
  • bone marrow derived stem cell
  • bone marrow derived stem cells
  • bone marrow-derived stem cells
  • bone-marrow derived stem cells
  • bone marrow stem cell
  • bone marrow stem cells
  • bone marrow stromal cells
  • jr-0301
  • prochymal
  • prochymal
  • remestemcel-l
  • remestemcel-l

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07177677Phase 1Sep 30, 2025Capital Medical University
NCT06997939Phase 1/Phase 2 (Phase 2)Jun 1, 2025Nantong University
NCT06750757Phase 4Feb 28, 2025American Hip Institute
NCT06662604Phase 3Oct 26, 2024Cairo University
NCT06392711Phase 1Oct 4, 2024University of Wisconsin
NCT06216028Phase 3Sep 30, 2024CELL Technologies Inc.
NCT06311513Phase 4Apr 30, 2024Arthritis Foundation, Emory University, Rockefeller University
NCT06400862Phase 1Feb 26, 2024Chinese University of Hong Kong
NCT06040957N/AJan 31, 2024University of Bologna
NCT06146062Phase 2Jan 2, 2024Assistance Publique - Hôpitaux de Paris, University of Paris
NCT06171906Phase 4Jan 1, 2024People's Liberation Army of China
NCT06063590Phase 1/Phase 2 (Phase 2)Nov 28, 2023Cellcolabs Clinical LTD., PDC-CRO
NCT06084988Phase 1/Phase 2 (Phase 2)Nov 8, 2023Cellcolabs Clinical LTD., PDC-CRO
NCT06001853Phase 2Nov 3, 2023Mayo Clinic
NCT06111846Phase 2Nov 1, 2023Guangzhou Medical University
NCT06070532Phase 1/Phase 2 (Phase 2)Oct 9, 2023Cellcolabs Clinical LTD.
NCT06087848Phase 1/Phase 2 (Phase 2)Oct 7, 2023Cellcolabs Clinical LTD.
NCT05881668Phase 1Sep 30, 2023Sun Yat-Sen University
NCT05705024Phase 2Sep 29, 2023Department of Defense, University of Illinois at Chicago
NCT06163833Phase 2Sep 19, 2023A.O. Ospedale Maggiore di Lodi, Fondazione IRCCS San Gerardo dei Tintori, Mario Negri Institute, University of Brescia
Showing 20 of 172 trials
Page 1 / 9

Organizations

Research & Development (226)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mesoblast, Inc.For profit171432005
University of Texas at HoustonAcademic/Hospital8532001
Guangzhou Medical UniversityAcademic/Hospital7122011
The Cleveland ClinicAcademic/Hospital7722020
Sun Yat-Sen UniversityAcademic/Hospital6532015
Harvard UniversityAcademic/Hospital5242001
TCA Cellular TherapyFor profit5522007
Universidad Autonoma de MadridAcademic/Hospital5332014
Cairo UniversityAcademic/Hospital4332014
Cellcolabs Clinical LTD.Academic/Hospital4412023
Duke UniversityAcademic/Hospital4042001
Johns Hopkins UniversityAcademic/Hospital4322001
Mayo ClinicAcademic/Hospital4332017
National Heart, Lung, and Blood Institute (NHLBI)Government4231999
People's Liberation Army of ChinaGovernment4422011
Royan InstituteAcademic/Hospital4422008
University of MiamiAcademic/Hospital4432004
University of MinnesotaAcademic/Hospital4222001
Autonomous University of MadridAcademic/Hospital3222014
Bioinova, s.r.o.For profit3312012
226 organizations
Page 1 / 12

Marketing (1)

OrganizationOrg typeRelationshipDate
Mesoblast, Inc.For profitNDADec 18, 2024