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Umbilical Cord BloodPhase 1NCT01235468

Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

A Phase 1 study testing ex vivo expansion in people with Umbilical Cord Blood and Stem Cell Transplantation, run by Dr. Avichai Shimoni MD.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
ex vivo expansion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2012to Nov 2015
Phase
Phase 1
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age > 18 years
  • hematological malignancy
  • standard indication for allogeneic transplantation
  • expected survival time over 12 weeks
  • no related or unrelated donor
  • availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Prior allogeneic transplantation
  • Pregnant or nursing women
  • Positive serology for hepatitis B or C
  • HIV positive
  • Left ventricular ejection fraction < 50%
Show all 9Show fewer
  • DLCO < 50%
  • Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
  • Treatment with other investigational drugs within 4 weeks of enrolling in this protocol

About this study

Official title: Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

Read the detailed description

Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

Being tested
ex vivo expansion
Keywords
umbilical cord blood, ex vivo expansion, engraftment, GVHD
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • ex vivo expansionBiological

    ex-vivo expansion of cord blood for transplantation

Study groups in NCT01235468
Study groupRoleWhat they receive
CB expnasionExperimentalex-vivo expansion of cord blood for transplantation
Receives: Biological: ex vivo expansion

What is being measured

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

  1. Safety

    Number of patients with adverse events during infusion

    Measured: 1 month

  2. engraftment

    Time to engraftment

    Measured: 3 months

  3. treatment-related toxicity

    Type and severity of adverse events after transplantation using the NCI CTC scale

    Measured: 3 months

  4. GVHD

    Number of patients with acute and chronic GVHD after transplantation

    Measured: 1 year

Secondary outcomes (2)

  1. Immunological reconstruction

    immunological reconstruction after transplantation measured by lymphocyte number and function

    Measured: 5 years

  2. relapse

    rate of disease recurrence

    Measured: 5 years

Timeline

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

  1. First posted5 Nov 2010 (estimated)
  2. Study startJun 2012
  3. Primary completionNov 2015 (estimated)
  4. Study completionNov 2015 (estimated)

Why it stopped: loss of support

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235468
Sponsor's protocol ID
SHEBA-10-7959-AN-CTIL
Status last verified
Dec 2015
First submitted
2 Nov 2010
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ex vivo expansion in people with Umbilical Cord Blood and Stem Cell Transplantation, run by Dr. Avichai Shimoni MD.

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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Safety (time frame: 1 month). The study lists 4 primary outcomes in all. 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 NCT01235468.

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 3 Dec 2015.

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