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Gene Therapy

Gene-Edited Stem Cell Therapy for HIV/AIDS

Q: Would I qualify to partake in this experiment?

<p>This clinical trial is recruiting 12 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive individuals aged between 18 and 75 years to participate. In order for applicants to be considered, they must meet the following criteria: Maximum age 75 years for cohort 1 and 65 years for cohort 2., Successful G-CSF/Plerixafor mobilisation of HSPC., Donating 7.5 x 10^6 CD34+ cells per kilogram in two aphereses., Demonstrated seropositivity with an R5 strain of HIV-1 virus, but no evidence of CXCR4-tropic virus infection, On cART treatment that has rendered</p>

Phase 1

Waitlist Available

Led By Amrita Y. Krishnan, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maximum age 75 years for cohort 1 and 65 years for cohort 2

HIV-1 R5 seropositive with no evidence of CXCR4-tropic virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 5

Awards & highlights

Study Summary

This trial will test whether it is safe to give a person with leukemia a new treatment that uses their own stem cells.

Who is the study for?

This trial is for HIV-1 infected patients under 75 years old, with controlled virus levels due to consistent antiretroviral therapy (cART) for at least a year, and specific CD4+ T-cell counts. They must not have significant heart issues or psychosocial conditions affecting study participation. Excluded are those with active hepatitis, pregnant or nursing women, recent investigational drug use, substance abuse history, certain hematologic diseases, recent opportunistic infections or malignancies.Check my eligibility

What is being tested?

The trial tests the safety of SB-728mR-HSPC infusion in HIV/AIDS patients after busulfan conditioning. SB-728mR-HSPC is a genetically modified stem/progenitor cell product aimed at altering the immune system to resist HIV more effectively.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion process itself and complications from busulfan conditioning like lowered blood counts leading to increased infection risk. Genetic modification might also pose risks that will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 75 or younger for cohort 1, and 65 or younger for cohort 2.

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I am HIV positive with only the R5 virus strain.

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I have been on HIV treatment with undetectable levels for at least a year.

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I do not have serious heart disease or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Toxicity in subjects who received SB-728mR-HSPC after each busulfan dose level

Secondary outcome measures

Number of CD34+ HSPC collected, gene modified, and released throughout the manufacturing process

Other outcome measures

Changes in CD4+ T-cell number after SB-728mR-HSPC infusion

Changes in CD4+ T-cell percentage after SB-728mR-HSPC infusion

Changes in CD4/CD8 ratio after SB-728mR-HSPC infusion

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2:Experimental Treatment1 Intervention

busulfan AUC levels: 12,000 µM*min (+/- 1,000)

Group II: Cohort 1:Experimental Treatment1 Intervention

target busulfan AUC levels: 8,000 µM*min (+/- 1,000)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,448 Total Patients Enrolled

Sangamo TherapeuticsIndustry Sponsor

28 Previous Clinical Trials

937 Total Patients Enrolled

California Institute for Regenerative Medicine (CIRM)OTHER

63 Previous Clinical Trials

3,136 Total Patients Enrolled

Media Library

SB-728mR-HSPC (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02500849 — Phase 1

HIV/AIDS Research Study Groups: Cohort 1:, Cohort 2:

HIV/AIDS Clinical Trial 2023: SB-728mR-HSPC Highlights & Side Effects. Trial Name: NCT02500849 — Phase 1

SB-728mR-HSPC (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02500849 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently welcoming new participants?

"Based on the information located at clinicaltrials.gov, this particular medical study is not presently open for enrollment. Initially posted in March 2016, it was last updated a few months ago; however, there are currently 238 other trials actively recruiting patients."

Answered by AI

Would I qualify to partake in this experiment?

"This clinical trial is recruiting 12 HIV-positive individuals aged between 18 and 75 years to participate. In order for applicants to be considered, they must meet the following criteria: Maximum age 75 years for cohort 1 and 65 years for cohort 2., Successful G-CSF/Plerixafor mobilisation of HSPC., Donating 7.5 x 10^6 CD34+ cells per kilogram in two aphereses., Demonstrated seropositivity with an R5 strain of HIV-1 virus, but no evidence of CXCR4-tropic virus infection, On cART treatment that has rendered"

Answered by AI

At what diverse locales is this investigation being conducted?

"At the moment, this experiment is hosted at 5 different medical centres. People located in San Francisco, Duarte and Norwalk can access these locations relatively easily. Additionally, there are also other sites that may be nearer to you; it might be beneficial to pick one close by if you plan on taking part in this clinical trial."

Answered by AI

Is this research initiative open to participants below the age of fifty-five?

"This clinical trial is limited to patients between the ages of 18 and 75. For those younger than 18, there are 57 trials available; whereas 176 studies cater to elderly participants that exceed 65 years old."

Answered by AI

Is the FDA's clearance granted for an infusion of SB-728mR-HSPC three days after busulfan conditioning?

"The safety rating for SB-728mR-HSPC Infusion 3 days following busulfan conditioning is 1, as this Phase 1 trial has only limited evidence to support its efficacy and security."

Answered by AI

Recent research and studies

Molecular Therapy - Methods & Clinical DevelopmentJournal

Preclinical Development and Qualification of Zfn-mediated CCR5 Disruption in Human Hematopoietic Stem/progenitor Cells

DiGiusto, David L, Paula M Cannon, Michael C Holmes, Lijing Li, Anitha Rao, Jianbin Wang, Gary Lee, et al.. 2016. “Preclinical Development and Qualification of Zfn-mediated CCR5 Disruption in Human Hematopoietic Stem/progenitor Cells”. Molecular Therapy - Methods & Clinical Development. Elsevier BV. doi:10.1038/mtm.2016.67.

clinicaltrials.govStudy

Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients

2016. "Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02500849.

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