HIV InfectionsPhase 1NCT00559416
Lymphocyte Infusions for the Treatment of HIV-Infected Patients Failing Anti-HIV Therapy
A Phase 1 study testing Cell Transfer in people with HIV Infections, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Some HIV-infected individuals have a white blood cell marker known as HLA-B*57 that appears to help control the progress of the disease; however, not all who have the HLA-B*57 marker are able to control the infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cell Transfer
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2007to 30 Sep 2016
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under this protocol, cell recipients must fulfill all of the following characteristics and conditions:
- Greater than or equal to 18 years old
- Ability to sign informed consent
- For women of child-bearing potential, negative result on a serum or urine pregnancy test; in addition, men and women of childbearing potential must agree to practice abstinence or use two methods of birth control/contraception (condoms, diaphragm or cervical cap with spermicide, IUD, or hormonal-based contraception) for at least 4 weeks after each cell infusion
- Willingness to comply with study requirements and procedures including storage of blood for possible future use to study HIV/AIDS, related diseases, or the immune system
- Willingness to permit HLA testing
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- Hematocrit greater than or equal to 27 percent, platelets greater than or equal to 25,000/mm (3)
- No significant underlying cardiac, renal, or hepatic disease (Creatinine less than 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 150 U/mL)
- HIV infection must be confirmed by ELISA and a confirmatory test (e.g. western blot if not previously documented, and patients must be under the care of a primary care physician.
- Viral load greater than 10,000 copies/mL on available optimized combination antiretroviral therapy, to include at least 3 drugs, one of which is a non-nucleoside reverse transcriptase inhibitor (NNRTI), integrase inhibitor, or protease inhibitor. Patients not on combination antiretroviral therapy will be eligible, but must be willing to resume combination antiretroviral therapy and to have had a viral load greater than 10,000 copies/mL after at least 2 weeks of therapy.
- Failure or intolerance of at least two previous combination antiretroviral regimens. Failure will be defined as an HIV viral load greater than 400 copies/mL while taking a given regimen.
- Recipient must be taking appropriate prophylaxis for opportunistic infections, as per Public Health Service (PHS) guidelines, unless there is intolerance to available medications.
- Screening CD4+ cell count less than or equal to 350 cells/mm(3) obtained within 6 weeks prior to study entry.
- Donor eligibility criteria as specified by the FDA will be followed, except for HIV testing. All donors will be HIV positive as per protocol and as described in the IND application. Under this protocol, cell donors must fulfill all of the following characteristics and conditions:
- Greater than or equal to 18 years old.
- Ability to sign informed consent.
- For women of child-bearing potential, negative result on a serum or urine pregnancy test.
- Willingness to comply with study requirements and procedures including storage of blood for possible future use to study HIV/AIDS, related diseases, or the immune system.
- Willingness to permit HLA testing.
- Matched to at least one HLA-B allele of the potential recipient. The
- match will be at a two-digit resolution HLA allele level of typing or higher.
- Hematocrit greater than or equal to 30 percent, platelets greater than or equal to 100,000/mm(3), white blood cells greater than or equal to 3.0 times 10(9)/L.
- No underlying cardiac, pulmonary, renal, or hepatic disease that would preclude patient from undergoing apheresis.
- HIV infection must be confirmed by ELISA and a confirmatory test (e.g. western blot if not previously on record, and patients must be under the care of a primary care physician.
- HIV infection for greater trhan or equal to 7 years.
- For patients with a history of no or minimal (one or two nucleotide reverse transcriptase inhibitor (NRTI) drugs) prior antiretroviral therapy: CD4+ cell count greater than or equal to 400 cells/mm(3) and HIV viral load less than 50 copies/mL, with no recorded HIV viral load obtained after acute HIV infection greater than 2,500 copies/mL. For patients currently receiving antiretroviral therapy: no antiretroviral therapy for a period of at least 7 years prior to starting antiretroviral therapy, with CD4+ cell count greater than or equal to 400 cells/mm(3) and HIV viral load < 50 copies/mL at the time of initiation of antiretroviral therapy, and no recorded HIV viral load obtained after acute HIV infection > 2,500 copies/mL. HIV viral loads obtained during acute HIV infection (within 6 months of the estimated date of seroconversion) will not be utilized for study inclusion/exclusion.
- Minimum wt of 110 lbs<TAB>
Who cannot join
- An individual will be ineligible to receive cells if one or more of the following conditions are present:
- Discordance with donor on antibody status of EBV, CMV, or HHV-8 if donor is antibody positive for EBV, CMV, or HHV-8.
- Malignancy requiring systemic therapy, or a history of malignancy that required myelotoxic chemotherapy.
- Active untreated opportunistic infection that requires systemic therapy. Patients with opportunistic infections who have received greater than 2 weeks of therapy will be eligible.
- Is pregnant or breast feeding.
- Severe psychiatric disorder that would interfere with adherence to protocol requirements. Individuals who have a stable psychiatric condition may be eligible.
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- Current use or a history of treatment with investigational agent(s) within 3 months of protocol enrollment. ARVs obtained through expanded access programs are permitted.
- Current use or a history of treatment with a systemic corticosteroid, immunosuppressive, or cytotoxic agent within 30 days of protocol enrollment.
- Any other medical condition for which the investigator believes cell transfer may be contraindicated.
- Ever been diagnosed with autoimmune vasculitis.
- An individual will be ineligible to donate cells if one or more of the following conditions are present:
- Ever having been diagnosed with any AIDS-defining illnesses
- Positive results on screening test for any of the following tests: HCV enzyme immunoassay (EIA) repeat reactive/ recombinant immunoblot (RIBA) confirmed, HBV/HCV NAT, HTLV-I/II antibodies, T.cruzi antibodies, HBsAg, or serologic test for syphilis (with positive confirmatory treponemal-based assay), unless the patient has received adequate therapy for syphilis. Donors with a positive West Nile Virus NAT are deferred for 120 days.
- Is pregnant or breast feeding
- HLA homozygous donor who is haplo-identical to recipient
- History of malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of cervix or colon
- ALT or AST greater than 2 times the upper limit of normal
- Been diagnosed with malaria
- Been diagnosed with Chagas disease
- Been diagnosed with babesiosis
- Received a dura mater (or brain covering) graft
- Been diagnosed with any neurological disease
- Relative had Creutzfeldt-Jakob disease
- Had a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal
- Had a sexual partner or a member of the household have a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal
- Severe psychiatric disorder that would interfere with adherence to protocol requirements. Individuals who have a stable psychiatric condition may be eligible.
- Current use or a history of treatment with investigational agent(s) within 3 months of protocol enrollment.
- Current use or a history of treatment with a systemic corticosteroid, immunosuppressive, or cytotoxic agent within 30 days of protocol enrollment.
- Any other medical condition for which the investigator believes apheresis may be contraindicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Immunologic and Virologic Response in HIV Infected Progressors After Infusion of Lymphocytes From HIV Infected "Elite" Long-Term Non-Progressors
Some HIV-infected individuals have a white blood cell marker known as HLA-B*57 that appears to help control the progress of the disease; however, not all who have the HLA-B*57 marker are able to control the infection. This study will examine the effects of giving white blood cells with HLA-B*57 from an individual who controls HIV infection to an individual who cannot control HIV infection, as a form of HIV treatment. All candidates will be screened with a medical history, physical examination, and blood and urine tests.
Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older who have the HLA-B*57 marker and are receiving care. Donor candidates must have positive HIV antibody tests for at least seven years with a recent CD4 cell count greater than 400 cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than 1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4 cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must have failed at least two prior combination antiretroviral regimes and are willing to receive or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne illnesses, or have other medical conditions that might interfere with the study. Recipient volunteers will be excluded if they have a medical history of malignant cancer or other medical conditions that might possibly interfere with the study.
Read more
Donors will undergo apheresis to separate white blood cells from circulating blood before the red blood cells and plasma are returned to the bloodstream. The procedure will take up to five hours, and donors will be required to return for additional tests. Donors may be asked to return for further white blood cell donations, a maximum of six procedures per year.
Recipients will undergo apheresis to obtain stem cells for possible use in the study, and will be admitted to an NIH Clinical Center inpatient unit to receive an infusion of white blood cells and undergo a series of blood tests both before and after the infusion. The infusion process will take two hours. After being discharged, recipients will be asked to return to the Clinical Center for monitoring and follow-up tests, and may receive further infusions.
Read the detailed description
Improvements in human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) treatments in the United States have made the disease in many cases a chronic illness. However, many individuals have failed multiple lines of standard therapy, and thus, development of new modes of salvage treatment is crucial. Restriction of viral replication, mediated by CD8+ cells, appears to play an important role in control of HIV replication. A subset of individuals, many of whom possess human leukocyte antigen (HLA) B*57 exhibit restriction of HIV type 1 viral replication to less than 50 copies/mL, presumably by a mechanism that is CD8+ T-cell mediated, and become elite long-term non-progressors (LTNP), who have no evidence of progressive immunodeficiency and no development of opportunistic complications during many years of follow-up. Other individuals, including those with HLA-B*57 show no evidence of control of HIV replication, and without antiretroviral therapy will develop progressive immunodeficiency and HIV-related opportunistic complications. In this exploratory study, we are investigating a novel cell transfer strategy: up to 3 patients with HIV infection have failed at least 2 standard regimens of antiretroviral therapy, have a CD4+ count under 200 cells/mm (3), and a plasma HIV viral load of greater than 10,000 copies/mL, will be administered 10 (10) peripheral blood mononuclear cells obtained by lymphapheresis from an "elite" LTNP matched to the recipient on at least one HLA-B allele. Up to 70 patients may be enrolled for screening to identify 3 donors and 3 recipients. Up to 3 infusions may be administered per patient, with each infusion occurring no more frequently than every 3 months. The primary endpoints will be the safety of the infusions and the survival of donor cells in the recipient. Changes in the recipient s CD4+ and CD8+ cell number, other immune parameters, and plasma HIV viral load will also be monitored closely for evidence of anti-HIV activity.
- Conditions
- HIV Infections
- Being tested
- Cell Transfer
- Keywords
- HIV/AIDS, HLA-B*57, Cell Transfer, HIV, treatment experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell TransferDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, survival of transferred cells.
Secondary outcomes (1)
Changes in immune and viral parameters (CD4, Plasma HIV levels)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study start8 Nov 2007
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559416
- Sponsor's protocol ID
- 080024
- Other IDs
- 08-CC-0024
- Status last verified
- 30 Sep 2016
- First submitted
- 15 Nov 2007
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Coffin JM. HIV population dynamics in vivo: implications for genetic variation, pathogenesis, and therapy. Science. 1995 Jan 27;267(5197):483-9. doi: 10.1126/science.7824947.
PubMed 7824947Rosenberg ES, Billingsley JM, Caliendo AM, Boswell SL, Sax PE, Kalams SA, Walker BD. Vigorous HIV-1-specific CD4+ T cell responses associated with control of viremia. Science. 1997 Nov 21;278(5342):1447-50. doi: 10.1126/science.278.5342.1447.
PubMed 9367954Kovacs JA, Lempicki RA, Sidorov IA, Adelsberger JW, Sereti I, Sachau W, Kelly G, Metcalf JA, Davey RT Jr, Falloon J, Polis MA, Tavel J, Stevens R, Lambert L, Hosack DA, Bosche M, Issaq HJ, Fox SD, Leitman S, Baseler MW, Masur H, Di Mascio M, Dimitrov DS, Lane HC. Induction of prolonged survival of CD4+ T lymphocytes by intermittent IL-2 therapy in HIV-infected patients. J Clin Invest. 2005 Aug;115(8):2139-48. doi: 10.1172/JCI23196. Epub 2005 Jul 14.
PubMed 16025158Migueles SA, Chairez C, Lin S, Gavil NV, Rosenthal DM, Pooran M, Natarajan V, Rupert A, Dewar R, Rehman T, Sherman BT, Adelsberger J, Leitman SF, Stroncek D, Morse CG, Connors M, Lane HC, Kovacs JA. Adoptive lymphocyte transfer to an HIV-infected progressor from an elite controller. JCI Insight. 2019 Sep 19;4(18):e130664. doi: 10.1172/jci.insight.130664.
PubMed 31415245
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic and Virologic Response in HIV Infected Progressors After Infusion of Lymphocytes From HIV Infected "Elite" Long-Term Non-Progressors
- ClinicalTrials.gov ID
- NCT00559416
- Acronym / sponsor ID
- 080024
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, HLA-B*57, Cell Transfer, HIV, treatment experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 8 Nov 2007
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 16 Nov 2007 (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.
Some HIV-infected individuals have a white blood cell marker known as HLA-B*57 that appears to help control the progress of the disease; however, not all who have the HLA-B*57 marker are able to control the infection. This study will examine the effects of giving white blood cells with HLA-B*57 from an individual who controls HIV infection to an individual who cannot control HIV infection, as a form of HIV treatment. All candidates will be screened with a medical history, physical examination, and blood and urine tests.
Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older who have the HLA-B*57 marker and are receiving care. Donor candidates must have positive HIV antibody tests for at least seven years with a recent CD4 cell count greater than 400 cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than 1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4 cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must have failed at least two prior combination antiretroviral regimes and are willing to receive or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne illnesses, or have other medical conditions that might interfere with the study. Recipient volunteers will be excluded if they have a medical history of malignant cancer or other medical conditions that might possibly interfere with the study.
Donors will undergo apheresis to separate white blood cells from circulating blood before the red blood cells and plasma are returned to the bloodstream. The procedure will take up to five hours, and donors will be required to return for additional tests. Donors may be asked to return for further white blood cell donations, a maximum of six procedures per year.
Recipients will undergo apheresis to obtain stem cells for possible use in the study, and will be admitted to an NIH Clinical Center inpatient unit to receive an infusion of white blood cells and undergo a series of blood tests both before and after the infusion. The infusion process will take two hours. After being discharged, recipients will be asked to return to the Clinical Center for monitoring and follow-up tests, and may receive further infusions.
Detailed description
Improvements in human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) treatments in the United States have made the disease in many cases a chronic illness. However, many individuals have failed multiple lines of standard therapy, and thus, development of new modes of salvage treatment is crucial. Restriction of viral replication, mediated by CD8+ cells, appears to play an important role in control of HIV replication. A subset of individuals, many of whom possess human leukocyte antigen (HLA) B*57 exhibit restriction of HIV type 1 viral replication to less than 50 copies/mL, presumably by a mechanism that is CD8+ T-cell mediated, and become elite long-term non-progressors (LTNP), who have no evidence of progressive immunodeficiency and no development of opportunistic complications during many years of follow-up. Other individuals, including those with HLA-B*57 show no evidence of control of HIV replication, and without antiretroviral therapy will develop progressive immunodeficiency and HIV-related opportunistic complications. In this exploratory study, we are investigating a novel cell transfer strategy: up to 3 patients with HIV infection have failed at least 2 standard regimens of antiretroviral therapy, have a CD4+ count under 200 cells/mm (3), and a plasma HIV viral load of greater than 10,000 copies/mL, will be administered 10 (10) peripheral blood mononuclear cells obtained by lymphapheresis from an "elite" LTNP matched to the recipient on at least one HLA-B allele. Up to 70 patients may be enrolled for screening to identify 3 donors and 3 recipients. Up to 3 infusions may be administered per patient, with each infusion occurring no more frequently than every 3 months. The primary endpoints will be the safety of the infusions and the survival of donor cells in the recipient. Changes in the recipient s CD4+ and CD8+ cell number, other immune parameters, and plasma HIV viral load will also be monitored closely for evidence of anti-HIV activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Under this protocol, cell recipients must fulfill all of the following characteristics and conditions:
- Greater than or equal to 18 years old
- Ability to sign informed consent
- For women of child-bearing potential, negative result on a serum or urine pregnancy test; in addition, men and women of childbearing potential must agree to practice abstinence or use two methods of birth control/contraception (condoms, diaphragm or cervical cap with spermicide, IUD, or hormonal-based contraception) for at least 4 weeks after each cell infusion
- Willingness to comply with study requirements and procedures including storage of blood for possible future use to study HIV/AIDS, related diseases, or the immune system
Key exclusion criteria (29 listed)
- An individual will be ineligible to receive cells if one or more of the following conditions are present:
- Discordance with donor on antibody status of EBV, CMV, or HHV-8 if donor is antibody positive for EBV, CMV, or HHV-8.
- Malignancy requiring systemic therapy, or a history of malignancy that required myelotoxic chemotherapy.
- Active untreated opportunistic infection that requires systemic therapy. Patients with opportunistic infections who have received greater than 2 weeks of therapy will be eligible.
- Is pregnant or breast feeding.
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 |
|---|---|---|
| Cell Transfer | Drug | – |
Primary outcome
Safety, survival of transferred cells.
1 secondary outcome
Changes in immune and viral parameters (CD4, Plasma HIV levels)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 7824947Coffin JM. HIV population dynamics in vivo: implications for genetic variation, pathogenesis, and therapy. Science. 1995 Jan 27;267(5197):483-9. doi: 10.1126/science.7824947.
- Background: PubMed 9367954Rosenberg ES, Billingsley JM, Caliendo AM, Boswell SL, Sax PE, Kalams SA, Walker BD. Vigorous HIV-1-specific CD4+ T cell responses associated with control of viremia. Science. 1997 Nov 21;278(5342):1447-50. doi: 10.1126/science.278.5342.1447.
- Background: PubMed 16025158Kovacs JA, Lempicki RA, Sidorov IA, Adelsberger JW, Sereti I, Sachau W, Kelly G, Metcalf JA, Davey RT Jr, Falloon J, Polis MA, Tavel J, Stevens R, Lambert L, Hosack DA, Bosche M, Issaq HJ, Fox SD, Leitman S, Baseler MW, Masur H, Di Mascio M, Dimitrov DS, Lane HC. Induction of prolonged survival of CD4+ T lymphocytes by intermittent IL-2 therapy in HIV-infected patients. J Clin Invest. 2005 Aug;115(8):2139-48. doi: 10.1172/JCI23196. Epub 2005 Jul 14.
- Derived from this study: PubMed 31415245Migueles SA, Chairez C, Lin S, Gavil NV, Rosenthal DM, Pooran M, Natarajan V, Rupert A, Dewar R, Rehman T, Sherman BT, Adelsberger J, Leitman SF, Stroncek D, Morse CG, Connors M, Lane HC, Kovacs JA. Adoptive lymphocyte transfer to an HIV-infected progressor from an elite controller. JCI Insight. 2019 Sep 19;4(18):e130664. doi: 10.1172/jci.insight.130664.
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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.
Joseph A Kovacs, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cell Transfer in people with HIV Infections, run by National Institutes of Health Clinical Center (CC) 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 27 inclusion and 29 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: stopped early, as of the sponsor's last update on 5 Jul 2018. 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.
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 stopped early. 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?
Safety, survival of transferred cells.. 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 NCT00559416, which also lists 4 linked publications.
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 5 Jul 2018.