deltatrials
Unknown PHASE2 INTERVENTIONAL 1-arm NCT01763086

Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant

Mesenchymal Stem Cells From Third-party Donors for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor: Guangdong Provincial People's Hospital

Updated 9 times since 2017 Last updated: Jan 15, 2013 Started: Jan 31, 2013 Primary completion: Jan 31, 2015 Completion: Jan 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Hematological Diseases and Mesenchymal Stem Cells, this trial is ongoing. The trial is conducted by Guangdong Provincial People's Hospital and has accumulated 9 data snapshots since 2013. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (PGF) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease(GVHD) development, respectively. Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. However, the efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly,...

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (PGF) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease(GVHD) development, respectively.

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. However, the efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors in treating patients with PGF after allo-HSCT.

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshotUnknown Status~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotUnknown Status~Jun 2018 – ~Dec 2019 · 18 months · monthly snapshotUnknown Status~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2023 · 30 months · monthly snapshotUnknown Status~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

  2. Sep 2024 — Present [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  4. Jul 2023 — Jul 2024 [monthly]

    Unknown Status PHASE2

  5. Jan 2021 — Jul 2023 [monthly]

    Unknown Status PHASE2

Show 4 earlier versions
  1. Dec 2019 — Jan 2021 [monthly]

    Unknown Status PHASE2

  2. Jun 2018 — Dec 2019 [monthly]

    Unknown Status PHASE2

  3. Jun 2017 — Jun 2018 [monthly]

    Unknown Status PHASE2

  4. Jan 2017 — Jun 2017 [monthly]

    Unknown Status PHASE2

    First recorded

Jan 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Guangdong Provincial People's Hospital
  • Guangzhou First People's Hospital
  • Guangzhou General Hospital of Guangzhou Military Command
  • Nanfang Hospital, Southern Medical University
  • Peking University People's Hospital
  • Southern Medical University, China
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Sun Yat-sen University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Zhongshan People's Hospital, Guangdong, China
Data source: Nanfang Hospital, Southern Medical University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations