Using mesenchymal stem cells to help HIV patients with immune response issues

A Clinical Study to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Combined With Antiviral Therapy in the Treatment of AIDS Patients With Immune Non-responder

This study is testing if using mesenchymal stem cells can help people with HIV who aren't responding well to their current treatments improve their immune response.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Qilu Cell Therapy Engineering Technology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05872659 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of mesenchymal stem cell therapy on patients with HIV who do not respond adequately to antiviral treatment. Participants will receive either mesenchymal stem cells or a saline placebo, and their immune response will be monitored through various tests. The study aims to determine both the safety and efficacy of this innovative therapy in improving immune function in these patients. By utilizing human umbilical cord-derived mesenchymal stem cells, the trial seeks to harness their regenerative and immunomodulatory properties to enhance patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are HIV-infected adults aged 18 and older who have been on antiviral therapy for at least 12 months but still have low CD4+ T lymphocyte counts.

Not a fit: Patients with active infections, certain viral co-infections, or significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve immune function in HIV patients who currently do not respond well to existing treatments.

How similar studies have performed: While the use of mesenchymal stem cells in other contexts has shown promise, this specific application in HIV treatment is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Confirmed HIV infection.
* ≥18 years old, gender unlimited.
* ≥12 months of continuous antiviral therapy and at least 2 viral loads (3 months or more apart) \< 50 Copies/mL at screening.
* The antiviral regimen was not changed in the 12 months prior to enrollment.
* CD4+T lymphocyte count \< 200 μL-1 in patients receiving antiviral therapy for more than 1 year and less than 2 years or \< 350 μL-1 in patients receiving antiviral therapy for ≥ 2 years.
* Understand and sign the informed consent.

Exclusion Criteria:

* Infection with other viruses: HBV-DNA positive, HCV RNA positive, anti-Hav IgM, anti-HDV IgM and anti-HEV IgM positive and ALT \>80 IU/L, anti-TP positive.
* Active and uncontrollable infection.
* Malignant tumor or tumor history.
* Complicated with abnormal function of heart, liver, lung, kidney and other major organs.
* When the laboratory test satisfies any item (WBC \< 3.5\*10\^9/L; PLT \< 80\*10\^9/L; HGB \< 100 g/L).
* Drug dependent.
* Pregnant and lactating women.
* Severe allergic constitution, or known allergy to the study drug and its components;
* Accepting immunosuppressants or other immunomodulators (including thymosin) or systemic cytotoxic agents within 6 months prior to screening.
* Participated in other clinical studies within 3 months prior to this study.
* patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.

Where this trial is running

Jinan, Shandong

• Shandong Public Health Clinical Center — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Chenfan liu — Shandong Public Health Clinical Center
• Study coordinator: Chenfan Liu

Conditions AIDS Virus; Disorder of Immune Reconstitution; HIV; mesenchymal stem cell; Immune Non-responder; CD4; AIDS; Immune reconstitution