Trials / Unknown
UnknownNCT03517631
An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.
A Pilot Study to Evaluate Efficacy and Safety of Multiplexed shRNA-modified CD34+ Cells in HIV-infected Patients.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Shanghai Public Health Clinical Center · Other Government
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of autologous CD34+ cells that stably express multiplexed shRNA to treat HIV infection.
Detailed description
CD34+ cells will be isolated from mobilized PBMC of HIV patients. The cells will be lentivirally transduced with multiplexed shRNAs in the same vector that target CCR5 and HIV genome. Such modified cells will be infused back to the patients who have received bulsufan preconditioning before infusion. The patients will then be evaluated for efficacy and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | shRNA-modified CD34+ cells | Infusion of CD34+ cells transduced with shRNAs. |
| DRUG | Low dose busulfan preconditioning | A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation. |
| DRUG | Busulfan preconditioning | A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation. |
Timeline
- Start date
- 2018-02-27
- Primary completion
- 2020-12-15
- Completion
- 2020-12-31
- First posted
- 2018-05-07
- Last updated
- 2020-02-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03517631. Inclusion in this directory is not an endorsement.