Hematological MalignanciesPhase 4NCT00838019
Intrabone Cord Blood Transplantation
A Phase 4 study testing Intrabone administration of umbilical cord blood in people with Hematological Malignancies, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Intrabone administration of umbilical cord blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hematological malignancies
- Indication of allogenic transplantation
- No suitable donor (related/unrelated)
- No suitable cord blood unit with enough cellularity for standard transplant
- Written informed consent
Who cannot join
- ECOG > 2
- Co-morbidities
- HIV positive serology
- Pregnancy or breastfeeding
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
BMT Unit Hematology Department Hospital Clinic
Barcelona, Barcelona, 08036
Montserrat Rovira, MD, +34932275428, mrovira@clinic.ub.es
Montserrat Rovira, MD
About this study
Official title: Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.
- Conditions
- Hematological Malignancies
- Being tested
- Intrabone administration of umbilical cord blood
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrabone administration of umbilical cord bloodProcedure or surgery
Single administration
| Study group | Role | What they receive |
|---|---|---|
| Cord blood | Experimental | Not described Receives: Procedure: Intrabone administration of umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of hematopoietic engraftment
Measured: days 14, 21, 28 after administration
Secondary outcomes (1)
Dynamics and chimerism of hematological engraftment
Measured: days 14, 21, 28 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Montserrat Rovira, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838019
- Sponsor's protocol ID
- TPH/SCU-IMed 01/08
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00838019
- Acronym / sponsor ID
- TPH/SCU-IMed 01/08
- Conditions
- Hematological Malignancies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 6 Feb 2009 (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.
The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cord blood | Experimental | Procedure: Intrabone administration of umbilical cord blood |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hematological malignancies
- Indication of allogenic transplantation
- No suitable donor (related/unrelated)
- No suitable cord blood unit with enough cellularity for standard transplant
- Written informed consent
Key exclusion criteria (5 listed)
- ECOG > 2
- Co-morbidities
- HIV positive serology
- Pregnancy or breastfeeding
- Psychiatric illness
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 |
|---|---|---|
| Intrabone administration of umbilical cord bloodSingle administration | Procedure or surgery | Cord blood |
Primary outcome
Kinetics of hematopoietic engraftment
Time frame: days 14, 21, 28 after administration
1 secondary outcome
Dynamics and chimerism of hematological engraftment
Time frame: days 14, 21, 28 after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
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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.
Montserrat Rovira, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrabone administration of umbilical cord blood in people with Hematological Malignancies, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 inclusion and 5 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 6 Feb 2009. 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 Spain. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Montserrat Rovira, MD (+34932275428, mrovira@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of hematopoietic engraftment (time frame: days 14, 21, 28 after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2009.