Hematologic MalignanciesHPDSCNCT00596999

A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders

An observational study of Hematologic Malignancies, run by Celgene Corporation at 1 site in United States.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess… Read more about this study

Who is it for?: Ages Up to 55 years
Conditions the study is for: Hematologic Malignancies
What is being tested?: UCB and HPDSC
Type of treatment: Surgery or procedure
How many people: 6 participants
Where: 1 siteUnited States
Study dates: May 2007to Dec 2013
Phase: Observational
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 Up to 55 years
All sexes
No healthy volunteers
Child, Adult

Study population: subjects requiring cord blood transplantation

Who may be able to join

suitable UCB collected from partially or fully HLA matched related donor
subject requires umbilical cord transplantation

Who cannot join

any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
major anticipated illness or organ failure incompatible with survival from stem cell transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

Louisiana State University Children's Hospital
New Orleans, Louisiana, 70118

Other trials in United States

About this study

Official title: A Single-Arm Study to Assess the Safety of Transplantation With Umbilical Cord Blood Augmented With Human Placental-Derived Stem Cells From Partially Matched Related Donors in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders

Conditions: Hematologic Malignancies
Being tested: UCB and HPDSC
Keywords: Myelodysplastic Syndrome (MDS), Acute myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Sickle Cell Disease (SCD), Beta Thalassemia, Inborn Errors of Metabolism, Severe Combined Immunodeficiency Disease (SCID)
Medical subject headings: Hematologic Neoplasms, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Sickle Cell, beta-Thalassemia, Metabolism, Inborn Errors, X-Linked Combined Immunodeficiency Diseases

What participants receive

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

UCB and HPDSCProcedure or surgery
single dose of UCB followed by one unit of HPDSC

Study groups in NCT00596999
Study group	Role	What they receive
1		all subjects will be treated with UCB and HPDSC Receives: Procedure: UCB and HPDSC

What is being measured

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

Incidence of GVHD, time to engraftment and survival
Measured: 2 years

Timeline

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

May 2007Dec 2013

First posted17 Jan 2008 (estimated)
Study startMay 2007
Primary completionJul 2013 (estimated)
Study completionDec 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00596999
Sponsor's protocol ID: CCT-HPDSC-001
Acronym: HPDSC
Status last verified: Nov 2007
First submitted: 8 Jan 2008
Last updated: 10 Apr 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematologic Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm Study to Assess the Safety of Transplantation With Umbilical Cord Blood Augmented With Human Placental-Derived Stem Cells From Partially Matched Related Donors in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders
ClinicalTrials.gov ID: NCT00596999
Acronym / sponsor ID: HPDSC / CCT-HPDSC-001
Conditions: Hematologic Malignancies
Keywords: Myelodysplastic Syndrome (MDS), Acute myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Sickle Cell Disease (SCD), Beta Thalassemia, Inborn Errors of Metabolism, Severe Combined Immunodeficiency Disease (SCID)
Study type: Observational
Recruitment status: Unknown status
Enrolment: 6 participants (estimated)
Lead sponsor: Celgene CorporationIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jul 2013 (estimated)
Study completion: Dec 2013 (estimated)
First posted: 17 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Procedure: UCB and HPDSCall subjects will be treated with UCB and HPDSC

Who may qualify

Ages: Up to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: subjects requiring cord blood transplantation

Key inclusion criteria (2 listed)

suitable UCB collected from partially or fully HLA matched related donor
subject requires umbilical cord transplantation

Key exclusion criteria (2 listed)

any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
major anticipated illness or organ failure incompatible with survival from stem cell transplant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UCB and HPDSCsingle dose of UCB followed by one unit of HPDSC	Procedure or surgery	1

Primary outcome

Incidence of GVHD, time to engraftment and survival
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.

Related trials for Hematologic Malignancies

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lolie Yu, MD principal investigator

Louisiana State University Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancies, run by Celgene Corporation at 1 site in United States.

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 2 inclusion and 2 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 10 Apr 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 United States. 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of GVHD, time to engraftment and survival (time frame: 2 years). 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 NCT00596999.

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 10 Apr 2012.