AIDS VirusEarly Phase 1NCT05872659
Mesenchymal Stem Cells for Immune Non-responder Patients With HIV Infection
A Early Phase 1 study testing normal saline and Mesenchymal stem cells in people with AIDS Virus and Disorder of Immune Reconstitution, run by Shandong Qilu Cell Therapy Engineering Technology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are: 1. Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS Virus, Disorder of Immune Reconstitution
- What is being tested?
- normal saline and Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2023to 15 Nov 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong
Chenfan Liu, 17862958810, 1780966676@qq.com
About this study
Official title: 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
The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are:
- Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response.
- Safety of human umbilical cord mesenchymal stem cells combined with antiviral therapy in AIDS patients with immune non-response.
Participants will receive CD4,CD4/CD8, and RNA viral load tests and will be randomly assigned to either saline or mesenchymal stem cell therapy.
Investigators will evaluate the safety and efficacy of mesenchymal stem cell therapy based on examination results.
Read the detailed description
Highly active antiretroviral therapy (HAART) is an effective means to inhibit virus replication, increase the number of CD4+T lymphocytes and reduce mortality in HIV-infected people. However, it has been found that around 10% - 40% of patients have not achieved ideal immune function reconstruction under the condition of good viral load control and are referred to as"inadequate immunological responders" or "immune non-responders" (INRs).
A series of intervention measures have been proposed for patients with immune non-response, including growth hormone therapy, immunosuppressive therapy, cytokine therapy, traditional Chinese medicine therapy, etc., but there is no specific and effective treatment in clinical practice.
Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multi-directional differentiation potential derived from mesoderm. MSCs have considerable therapeutic effects due to their migration, differentiation, immune-modulation, and regeneration abilities. The immunomodulatory effect of mesenchymal stem cells can inhibit the excessive immune activation in patients. At the same time, the paracrine effect of mesenchymal stem cells can also regulate the disordered microenvironment and promote the repair of damaged cells and tissues.
This is a randomised, placebo-controlled, clinical trial to evaluate the safety and feasibility of a 3-doses treatment regimen with MSCs (1 million cells/Kg MSCs, months 0-1-2) in HIV infected adults with immune non-response. Subjects are block randomised (1:1) to receive either MSCs (n=10), or placebo (n=10), as the control treatment. Changes in CD4+Tcount and CD4/8，adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 12 months, that includes 7 visits.
- Conditions
- AIDS Virus, Disorder of Immune Reconstitution
- Being tested
- normal saline, Mesenchymal stem cells
- Keywords
- HIV, mesenchymal stem cell, Immune Non-responder, CD4, AIDS, Immune reconstitution
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
iv at D0, D30, D60
Mesenchymal stem cellsBiological
iv at D0, D30, D60
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants will receive continuous antiviral therapy and saline placebo (iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks. Receives: Other: normal saline |
| Treatment group | Experimental | Participants will receive continuous antiviral therapy and Mesenchymal stem cells (1*10^6/kg subject weight, iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks. Receives: Biological: Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD4+T cell counts
the total CD4+T cell counts compared with CD4 T cell counts at baseline
Measured: Change from Baseline at 12 months
Secondary outcomes (3)
change in CD4/CD8
the value of CD4/CD8 compared with CD4/CD8 value at baseline
Measured: Change from Baseline at 12 months
change in RNA viral load
the RNA viral load compared with RNA viral load at baseline
Measured: Change from Baseline at 12 months
The incidence of opportunistic infections
Incidence of opportunistic infections throughout the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start16 Apr 2023
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Public Health Clinical Center
- Responsible party
- Sponsor
- Investigators
- Chenfan liu, Principal investigator, Shandong Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872659
- Sponsor's protocol ID
- MSCT-A-22
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05872659
- Acronym / sponsor ID
- MSCT-A-22
- Conditions
- AIDS Virus, Disorder of Immune Reconstitution
- Keywords
- HIV, mesenchymal stem cell, Immune Non-responder, CD4, AIDS, Immune reconstitution
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shandong Public Health Clinical Center
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are:
- Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response.
- Safety of human umbilical cord mesenchymal stem cells combined with antiviral therapy in AIDS patients with immune non-response.
Participants will receive CD4,CD4/CD8, and RNA viral load tests and will be randomly assigned to either saline or mesenchymal stem cell therapy.
Investigators will evaluate the safety and efficacy of mesenchymal stem cell therapy based on examination results.
Detailed description
Highly active antiretroviral therapy (HAART) is an effective means to inhibit virus replication, increase the number of CD4+T lymphocytes and reduce mortality in HIV-infected people. However, it has been found that around 10% - 40% of patients have not achieved ideal immune function reconstruction under the condition of good viral load control and are referred to as"inadequate immunological responders" or "immune non-responders" (INRs).
A series of intervention measures have been proposed for patients with immune non-response, including growth hormone therapy, immunosuppressive therapy, cytokine therapy, traditional Chinese medicine therapy, etc., but there is no specific and effective treatment in clinical practice.
Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multi-directional differentiation potential derived from mesoderm. MSCs have considerable therapeutic effects due to their migration, differentiation, immune-modulation, and regeneration abilities. The immunomodulatory effect of mesenchymal stem cells can inhibit the excessive immune activation in patients. At the same time, the paracrine effect of mesenchymal stem cells can also regulate the disordered microenvironment and promote the repair of damaged cells and tissues.
This is a randomised, placebo-controlled, clinical trial to evaluate the safety and feasibility of a 3-doses treatment regimen with MSCs (1 million cells/Kg MSCs, months 0-1-2) in HIV infected adults with immune non-response. Subjects are block randomised (1:1) to receive either MSCs (n=10), or placebo (n=10), as the control treatment. Changes in CD4+Tcount and CD4/8，adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 12 months, that includes 7 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: normal salineParticipants will receive continuous antiviral therapy and saline placebo (iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks. |
| Treatment group | Experimental | Biological: Mesenchymal stem cellsParticipants will receive continuous antiviral therapy and Mesenchymal stem cells (1*10^6/kg subject weight, iv, 100 mL) treatment on Day 0，Day30，Day60 and followed up for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal salineiv at D0, D30, D60 | Other | Control group |
| Mesenchymal stem cellsiv at D0, D30, D60 | Biological | Treatment group |
Primary outcome
Change in CD4+T cell counts
Time frame: Change from Baseline at 12 months
the total CD4+T cell counts compared with CD4 T cell counts at baseline
3 secondary outcomes
change in CD4/CD8
Time frame: Change from Baseline at 12 months
change in RNA viral load
Time frame: Change from Baseline at 12 months
The incidence of opportunistic infections
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenfan liu principal investigator
Shandong Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing normal saline and Mesenchymal stem cells in people with AIDS Virus and Disorder of Immune Reconstitution, run by Shandong Qilu Cell Therapy Engineering Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenfan Liu (17862958810, 1780966676@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD4+T cell counts (time frame: Change from Baseline at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.