Discordant Immunological Response in HIV Infected SubjectsPhase 1/2NCT02290041
Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
A Phase 1/2 study testing Infusion of MSC in people with Discordant Immunological Response in HIV Infected Subjects, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial summary
Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discordant Immunological Response in HIV Infected Subjects
- What is being tested?
- Infusion of MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2017to 30 Jul 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection
- Age> 18 years, both sexes
- In treatment with antiretroviral therapy (ART)
- Sustained HIV viral load <50 copies / ml for ≥ 1 years prior to study entry
- CD4 + cell count < 350/mL
- Immunological discordant response defined as: an increase <75 or <150 in CD4+ cell counts within one or two years of undetectable viraemia, respectively; or CD4 + cell count <350/mcl after 3 years of ART and undetectable viraemia (<50 copies/ml) ≥ 1 year
- Writen informed consent
- In women of child bearing potential or her partners:commitment to use contraceptive method of proved efficiency throughout the duration of the clinical trial
Who cannot join
- Pregnancy, breastfeeding, or refusal to the use of contraceptive methods
- Opportunistic infections in the last 12 months prior to study entry
- Active co-infection with hepatitis B virus/hepatitis C virus
- Child Pugh's scale stage C cirrhosis of the liver of any a aetiology
- Portal hypertension and / or hypersplenism of any aetiology
- Malignant neoplasia
- Treatment with steroids, immunomodulators, interferon, chemotherapy or any other medicinal product that could modify the number of CD4+ within the last 12 months prior to study entry
- Confirmed analytical 3 or 4 grade (AIDS Clinical Trials Group scale) abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Phase I/II, of Test of Concept, Blind Double, Randomized, Controlled With Placebo, to Assess the Safety and Efficiency of the Treatment With Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue Expanded, in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects
Read the detailed description
This is a phase I-II, randomised, placebo-controlled, clinical trial, currently ongoing in a single Spanish hospital (Hospital Virgen del Rocío, Seville), to evaluate the safety and feasibility of a 4-doses treatment regimen with MSCs (1 million cells/Kg MSCs, weeks 0-4-8-20) in HIV infected adults with swith discordant virological and immunological response to antiretroviral therapy. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 15 days, receiving unblinded cell therapy. In the second phase of the trial, subjects are block randomised (1:1) to receive either MSCs (n=5), or placebo (n=5), as the control treatment. Immune response variables, adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 24 months, that includes 17 visits according to a decreasing frequency rate. Intention to treat, and per protocol, and safety analysis will be performed.
- Being tested
- Infusion of MSC, Infusion of placebo
- Keywords
- mesenchymal stem cells, HIV Infection, discordant immunological response
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of MSCDrug
Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).
Infusion of placeboDrug
Also called Placebo
Infusion of placebo (weeks 0-4-8-20)
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue Receives: Drug: Infusion of MSC |
| Placebo | Placebo comparator | Intravenous infusion of 4 doses of Placebo Receives: Drug: Infusion of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Incidence of adverse reactions grade 3 and 4 according to DAIDs scale
Measured: 24 months
Incidence of opportunist diseases
Measured: 24 months
Changes in CD4+ cell count and CD4+/CD8+ ratio
Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry
Measured: 28 days after the 4th infusion MSCs/placebo
Secondary outcomes (1)
T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start8 Feb 2017
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Discordant Immunological Response in HIV Infected SubjectsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Responsible party
- Sponsor
- Investigators
- Luis F. López Cortés, MD, Study chair, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290041
- Sponsor's protocol ID
- CeTMAd-VIH-2014
- Status last verified
- Mar 2020
- First submitted
- 10 Nov 2014
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trujillo-Rodriguez M, Viciana P, Rivas-Jeremias I, Alvarez-Rios AI, Ruiz-Garcia A, Espinosa-Ibanez O, Arias-Santiago S, Martinez-Atienza J, Mata R, Fernandez-Lopez O, Ruiz-Mateos E, Gutierrez-Valencia A, Lopez-Cortes LF. Mesenchymal stromal cells in human immunodeficiency virus-infected patients with discordant immune response: Early results of a phase I/II clinical trial. Stem Cells Transl Med. 2021 Apr;10(4):534-541. doi: 10.1002/sctm.20-0213. Epub 2020 Dec 2.
PubMed 33264515
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase I/II, of Test of Concept, Blind Double, Randomized, Controlled With Placebo, to Assess the Safety and Efficiency of the Treatment With Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue Expanded, in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
- ClinicalTrials.gov ID
- NCT02290041
- Acronym / sponsor ID
- CeTMAd-VIH-2014
- Keywords
- mesenchymal stem cells, HIV Infection, discordant immunological response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 13 Nov 2014 (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.
Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects
Detailed description
This is a phase I-II, randomised, placebo-controlled, clinical trial, currently ongoing in a single Spanish hospital (Hospital Virgen del Rocío, Seville), to evaluate the safety and feasibility of a 4-doses treatment regimen with MSCs (1 million cells/Kg MSCs, weeks 0-4-8-20) in HIV infected adults with swith discordant virological and immunological response to antiretroviral therapy. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 15 days, receiving unblinded cell therapy. In the second phase of the trial, subjects are block randomised (1:1) to receive either MSCs (n=5), or placebo (n=5), as the control treatment. Immune response variables, adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 24 months, that includes 17 visits according to a decreasing frequency rate. Intention to treat, and per protocol, and safety analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10)
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Drug: Infusion of MSCIntravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue |
| Placebo | Placebo comparator | Drug: Infusion of placeboIntravenous infusion of 4 doses of Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed HIV infection
- Age> 18 years, both sexes
- In treatment with antiretroviral therapy (ART)
- Sustained HIV viral load <50 copies / ml for ≥ 1 years prior to study entry
- CD4 + cell count < 350/mL
Key exclusion criteria (8 listed)
- Pregnancy, breastfeeding, or refusal to the use of contraceptive methods
- Opportunistic infections in the last 12 months prior to study entry
- Active co-infection with hepatitis B virus/hepatitis C virus
- Child Pugh's scale stage C cirrhosis of the liver of any a aetiology
- Portal hypertension and / or hypersplenism of any aetiology
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 |
|---|---|---|
| Infusion of MSCIntravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20). | Drug | Mesenchymal stem cells |
| Infusion of placeboAlso: PlaceboInfusion of placebo (weeks 0-4-8-20) | Drug | Placebo |
Primary outcome
Incidence of adverse reactions
Time frame: 24 months
Incidence of adverse reactions grade 3 and 4 according to DAIDs scale
Incidence of opportunist diseases
Time frame: 24 months
Changes in CD4+ cell count and CD4+/CD8+ ratio
Time frame: 28 days after the 4th infusion MSCs/placebo
Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry
1 secondary outcome
T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 33264515Trujillo-Rodriguez M, Viciana P, Rivas-Jeremias I, Alvarez-Rios AI, Ruiz-Garcia A, Espinosa-Ibanez O, Arias-Santiago S, Martinez-Atienza J, Mata R, Fernandez-Lopez O, Ruiz-Mateos E, Gutierrez-Valencia A, Lopez-Cortes LF. Mesenchymal stromal cells in human immunodeficiency virus-infected patients with discordant immune response: Early results of a phase I/II clinical trial. Stem Cells Transl Med. 2021 Apr;10(4):534-541. doi: 10.1002/sctm.20-0213. Epub 2020 Dec 2.
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.
Luis F. López Cortés, MD study chair
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infusion of MSC in people with Discordant Immunological Response in HIV Infected Subjects, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 4 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 adverse reactions (time frame: 24 months). The study lists 3 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 NCT02290041, which also lists 1 linked publication.
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 4 Mar 2020.