Stem Cell TransplantationPhase 1NCT00062543
Hepatic Artery Infusion of CD34+ Cells
A Phase 1 study testing Hepatic artery infusion of CD34+ cells and Cobe Spectra in people with Stem Cell Transplantation and Liver Diseases, run by M.D. Anderson Cancer Center.
Trial summary
The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stem Cell Transplantation, Liver Diseases
- What is being tested?
- Hepatic artery infusion of CD34+ cells and Cobe Spectra
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Oct 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.
- The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.
- The patient must have complete donor chimerism.
Who cannot join
- Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for infusion.
- Patients with graft versus host disease (GVHD).
- Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.
- Patients with active hepatitis B or C.
About this study
Official title: Hepatic Artery Infusion of CD34+ Cells, Isolated by the Isolex 300i Device, in Stem Cell Transplant Recipients With Hepatic Failure Due to Veno-occlusive Disease
The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.
Read the detailed description
Participants in this study have received stem cell transplantation. As a result of this procedure, participants have developed severe liver dysfunction. Researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. Before taking part in this study, women able to have children must have a negative blood pregnancy test.
Participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. This will be done after liver disease has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3 days. During that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place.
During the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. Participants will receive different drugs by vein to decrease the risk of transfusion reaction. After completing donor cell infusion, the catheter will be removed.
After participants are released from the hospital, they will have periodic evaluation of liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. Around Days 28 and 90, participants will have liver biopsy.
This is an investigational study. A total of 10 patients will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Stem Cell Transplantation, Liver Diseases
- Being tested
- Hepatic artery infusion of CD34+ cells, Cobe Spectra
- Keywords
- Severe hepatic dysfunction post stem cell transplantation, Stem Cell Transplantation, Hepatic Artery Infusion, Liver Diseases, CD34+ Cells, SCT
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic artery infusion of CD34+ cellsProcedure or surgery
Donor's cells infused directly into liver through a groin catheter (hepatic artery).
Cobe SpectraDevice
Also called blood cell separator
Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Artery Infusion | Experimental | Donor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes. Cells given as a dose escalation study. First cohort of 3 patients receive 1 * 106 CD34+ cells/kg. Next 3 patients receive 2.5 * 106 CD34+cells/kg. Next 3 patients receive 5 * 106 CD34+ cells/kg. Less than 1 * 105 T cells/kg administered. Receives: Procedure: Hepatic artery infusion of CD34+ cells; Device: Cobe Spectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startMay 2002
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeev Estrov, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062543
- Sponsor's protocol ID
- ID02-167
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2003
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Artery Infusion of CD34+ Cells, Isolated by the Isolex 300i Device, in Stem Cell Transplant Recipients With Hepatic Failure Due to Veno-occlusive Disease
- ClinicalTrials.gov ID
- NCT00062543
- Acronym / sponsor ID
- ID02-167
- Conditions
- Stem Cell Transplantation, Liver Diseases
- Keywords
- Severe hepatic dysfunction post stem cell transplantation, Stem Cell Transplantation, Hepatic Artery Infusion, Liver Diseases, CD34+ Cells, SCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Jun 2003 (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 primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.
Detailed description
Participants in this study have received stem cell transplantation. As a result of this procedure, participants have developed severe liver dysfunction. Researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. Before taking part in this study, women able to have children must have a negative blood pregnancy test.
Participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. This will be done after liver disease has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3 days. During that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place.
During the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. Participants will receive different drugs by vein to decrease the risk of transfusion reaction. After completing donor cell infusion, the catheter will be removed.
After participants are released from the hospital, they will have periodic evaluation of liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. Around Days 28 and 90, participants will have liver biopsy.
This is an investigational study. A total of 10 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Artery Infusion | Experimental | Procedure: Hepatic artery infusion of CD34+ cells, Device: Cobe SpectraDonor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes. Cells given as a dose escalation study. First cohort of 3 patients receive 1 * 106 CD34+ cells/kg. Next 3 patients receive 2.5 * 106 CD34+cells/kg. Next 3 patients receive 5 * 106 CD34+ cells/kg. Less than 1 * 105 T cells/kg administered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.
- The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.
- The patient must have complete donor chimerism.
Key exclusion criteria (4 listed)
- Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for infusion.
- Patients with graft versus host disease (GVHD).
- Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.
- Patients with active hepatitis B or C.
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 |
|---|---|---|
| Hepatic artery infusion of CD34+ cellsDonor's cells infused directly into liver through a groin catheter (hepatic artery). | Procedure or surgery | Hepatic Artery Infusion |
| Cobe SpectraAlso: blood cell separatorMononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra). | Device | Hepatic Artery Infusion |
Primary outcome
Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.
Time frame: 3 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Zeev Estrov, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hepatic artery infusion of CD34+ cells and Cobe Spectra in people with Stem Cell Transplantation and Liver Diseases, run by M.D. Anderson Cancer Center.
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 4 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 29 Oct 2018. 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?
Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival. (time frame: 3 Years). 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 29 Oct 2018.