Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02290041 |
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Recruitment Status :
Completed
First Posted : November 13, 2014
Last Update Posted : March 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Discordant Immunological Response in HIV Infected Subjects | Drug: Infusion of MSC Drug: Infusion of placebo | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10) |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 8, 2017 |
| Actual Primary Completion Date : | July 30, 2019 |
| Actual Study Completion Date : | July 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mesenchymal stem cells
Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue
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Drug: Infusion of MSC
Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20). |
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Placebo Comparator: Placebo
Intravenous infusion of 4 doses of Placebo
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Drug: Infusion of placebo
Infusion of placebo (weeks 0-4-8-20)
Other Name: Placebo |
- 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
- T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks [ Time Frame: 48 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290041
| Spain | |
| Virgen del Rocío University Hospital | |
| Seville, Spain, 41013 | |
| Study Chair: | Luis F. López Cortés, MD | Hospitales Universitarios Virgen del Rocío |
| Responsible Party: | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud |
| ClinicalTrials.gov Identifier: | NCT02290041 |
| Other Study ID Numbers: |
CeTMAd-VIH-2014 |
| First Posted: | November 13, 2014 Key Record Dates |
| Last Update Posted: | March 4, 2020 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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mesenchymal stem cells HIV Infection discordant immunological response |
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Viremia Virus Diseases Infections Sepsis |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |

