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AzTrials

Graft-Versus-Host DiseasePhase 1/2GVHD-MSCNCT01549665

Umbilical Cord Blood-derived Mesenchymal Stem Cells for the Treatment of Steroid-refractory Acute or Chronic Graft-versus-host-disease

A Phase 1/2 study testing Human umbilical cord blood-derived mesenchymal stem cells in people with Graft-Versus-Host Disease and GVHD, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or chronic disabilities. Read more about this study

Who is it for?
Ages 1 day to 30 years
What is being tested?
Human umbilical cord blood-derived mesenchymal stem cells
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Jan 2012to Dec 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Steroid-refractory acute or chronic graft-versus-host-disease
  • Acquisition of consent form
  • 0-30 years of age

Who cannot join

  • Withdrawal from the study
  • Progression of underlying hematologic diseases
  • Severe adverse effects related to the investigational drug

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Department of Pediatrics, Samsung Medical Center

    Seoul

    Hong Hoe Koo, MD, PhD, +82-2-3410-3524, hhkoo.koo@samsung.com

    Keon Hee Yoo, M.D., Ph.D., +82-2-3410-3532, hema2170@skku.edu

    Recruiting

Other trials in South Korea

About this study

Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be effective for some patients, outcomes of those who are refractory to corticosteroid are dismal. Secondary agents can be used for steroid-refractory cases; however, their efficacy is variable and usually limited. The quality of life issue of chronic GVHD is especially important for pediatric survivors who have longer life expectancy than adults. Many in-vitro and in-vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and possibilities of treating diseases caused by immune dysregulation such as GVHD. Recent data revealed that bone marrow-derived MSCs were very useful to treat steroid-refractory acute GVHD, which led to improved overall survival compared with controls. More recently, a number of reports suggest MSCs may also be useful in treating chronic GVHD as well as acute GVHD. It has been also reported that third party MSCs are also useful as well as those from autologous or HLA-matched donors. The investigator recently demonstrated that MSCs obtained from umbilical cord blood (UCB) have similar immunosuppressive properties as bone marrow-MSCs. UCB-MSCs can be obtained without doing any harm to donors that it may be more appropriate source of MSCs than bone marrow for off-the-shelf use. However, little is known about the safety and efficacy of UCB-MSCs in treating GVHD. Therefore, the investigator designed this study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric patients with steroid-refractory acute or chronic GVHD.

Being tested
Human umbilical cord blood-derived mesenchymal stem cells
Keywords
Graft-Versus-Host Disease, GVHD, Hematopoietic Stem Cell Transplantation, Stem Cell Transplantation, Allogeneic hematopoietic transplant, Mesenchymal Stem Cells, Unrelated Donors, Cord Blood Stem Cell Transplantation
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human umbilical cord blood-derived mesenchymal stem cellsBiological

    Also called PROMOSTEM®

    1st infusion(1x1,000,000 hMSC/kg)IV, 2nd infusion(2x1,000,000 hMSC/kg)IV and 3rd infusion(3x1,000,000 hMSC/kg)IV if no complete response at 28 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of UCB-MSC in SR-GVHD

    • Vital sign
    • Physical examination
    • ECOG performance status
    • Mixed Lymphocyte Reaction(MLR)
    • Adverse effects related to infusion

    Measured: 180 days

Secondary outcomes (1)

  1. Complete, Partial Response Rate at 28 and 180 Days in participants with SR-GVHD treated with UCB-MSC

    • Complete Response(CR) rate(%) = (Number of CR/Number of Participants)x100
    • Partial Response(PR)rate(%) = (Number of PR/Number of Participants)x100

    Measured: 180 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01549665
Sponsor's protocol ID
MP-CR-008
Acronym
GVHD-MSC
Status last verified
Mar 2012
First submitted
23 Feb 2012
Last updated
16 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Human umbilical cord blood-derived mesenchymal stem cells in people with Graft-Versus-Host Disease and GVHD, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of UCB-MSC in SR-GVHD (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01549665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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