Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02290041 | Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response | PHASE1 | COMPLETED | 5 | — | — | Feb 8, 2017 | Jul 30, 2019 | Mar 4, 2020 | 1 | Spain |
Incidence of adverse reactions grade 3 and 4 according to DAIDs scale
Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry
| Arm | Type | Description |
|---|---|---|
| Mesenchymal stem cells | EXPERIMENTAL | Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue |
| Placebo | PLACEBO_COMPARATOR | Intravenous infusion of 4 doses of Placebo |
| Name | Type | Description |
|---|---|---|
| Infusion of MSC | DRUG | 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 placebo | DRUG | Infusion of placebo (weeks 0-4-8-20) |
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...