AIDSPhase 1/2NCT05939167
Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
A Phase 1/2 study testing mesenchymal stem cell and saline in people with AIDS, run by Cell Energy Life Sciences Group Co. LTD at 4 sites in China.
Trial summary
The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS
- What is being tested?
- mesenchymal stem cell and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesChina
- Study dates
- 10 Dec 2023to 10 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection, aged 18-65, both genders
- CD4+T count less than 500 cells/ul at baseline.
- No serious AIDS related events. 3. could understand and sign the informed consent form and comply with the requirements of this study.
- 4. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study
Who cannot join
- have HBV/HCV/HDV/HEV infection, and the virological test is positive.
- The viral load for CMV and EBV is more than 1000 copies/ML.
- have HIV-2 infection.
- have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
- received treatment of hormones or other immunosuppressive drugs for a long time.
- with serious AIDS related or unrelated events.
Show all 13Show fewer
- received immunosuppressive drugs or systemic cytotoxic drugs for more than 3 months before recruiting
- have poor compliance during treatment.
- drug addiction within 6 months, or the urine drug test is positive
- participate in other clinical trials currently
- pregnant, breastfeeding, or have fertility requirements.
- unable or unwilling to provide informed consents, or unable to comply with research requirements.
- Other serious situations that may hinder clinical trials.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing 302 Hospital
Beijing
Fu-Sheng Wang, Doctor, 8610-13671005510, fswang302@163.com
Fu-Sheng Wang, Doctor
- Recruiting
Beijing YouAn Hospital
Beijing
Li-Jun Sun, Doctor
- Recruiting
Shenzhen Third People's Hospital
Shenzhen
Fu-Xiang Wang, Doctor
- Recruiting
The Fifth Hospital of Shijiazhuang
Shijiazhuang
Er-Hei Dai, Doctor
About this study
Official title: A Double-blind, Randomized Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.
Read the detailed description
Mesenchymal stem cells (MSCs) possess immunomodulatory, anti-inflammatory, and regenerative properties. The safety and effectiveness of MSCs have been investigated in various clinical trials for the treatment of several disorders, including graft-versushost disease, inflammatory bowel disease, and multiple sclerosis. It has been reported that MSC treatment in HIV-infected patients with immunological nonresponders resulted in a significant increase in circulating CD4+ T lymphocytes and a decrease of the activation of T lymphocytes and soluble inflammation mediator levels without significant adverse effects or loss of viremia control. However, the therapeutic efficacy of MSC treatment for AIDS patients at late stage is not well-understood. This study aims to investigate the safety and efficacy of MSC treatment for AIDS patients at late stage.
- Conditions
- AIDS
- Being tested
- mesenchymal stem cell, saline
- 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.
mesenchymal stem cellDrug
Also called umbilical cord derived MSCs
Mesenchymal stem cell dose is 0.75-1.0×10*6/kg and is transplanted by intravenous infusion. For the mesenchymal stem cell standard treatment group, the cells are used for three times(at week 0, 2,4 after recruitment) and the mesenchymal stem cell enhanced treatment group, the cells are used for six times(at week 0, 2,4,24,26,28 after recruitment).
salineOther
saline is used as placebo in the placebo comparator group
| Study group | Role | What they receive |
|---|---|---|
| placebo control | Placebo comparator | use saline Receives: Other: saline |
| mesenchymal stem cells standard treatment | Experimental | transplant mesenchymal stem cells for 3 times Receives: Drug: mesenchymal stem cell |
| mesenchymal stem cells enhanced treatment | Experimental | transplant mesenchymal stem cells for 6 times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with side effects in MSCs treatment groups
Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.
Measured: 48 weeks
CD4+ T cell counts after MSCs transfusion
at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline
Measured: 48 weeks
Secondary outcomes (1)
HIV RNA viral load
At week 12, 24 and 48, test HIV RNA viral load in participants' blood using RT-PCR and compare with baseline.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start10 Dec 2023
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Energy Life Sciences Group Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital, Shenzhen Third People's Hospital, Fifth Hospital of Shijiazhuang City, Beijing YouAn Hospital
- Responsible party
- Sponsor
- Investigators
- Fu-Sheng Wang, Doctor, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939167
- Sponsor's protocol ID
- 2022YFC2304403
- Status last verified
- Aug 2025
- First submitted
- 15 May 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage
- ClinicalTrials.gov ID
- NCT05939167
- Acronym / sponsor ID
- 2022YFC2304403
- Conditions
- AIDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cell Energy Life Sciences Group Co. LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital, Shenzhen Third People's Hospital, Fifth Hospital of Shijiazhuang City, Beijing YouAn Hospital
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 11 Jul 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 study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.
Detailed description
Mesenchymal stem cells (MSCs) possess immunomodulatory, anti-inflammatory, and regenerative properties. The safety and effectiveness of MSCs have been investigated in various clinical trials for the treatment of several disorders, including graft-versushost disease, inflammatory bowel disease, and multiple sclerosis. It has been reported that MSC treatment in HIV-infected patients with immunological nonresponders resulted in a significant increase in circulating CD4+ T lymphocytes and a decrease of the activation of T lymphocytes and soluble inflammation mediator levels without significant adverse effects or loss of viremia control. However, the therapeutic efficacy of MSC treatment for AIDS patients at late stage is not well-understood. This study aims to investigate the safety and efficacy of MSC treatment for AIDS patients at late stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo control | Placebo comparator | Other: salineuse saline |
| mesenchymal stem cells standard treatment | Experimental | Drug: mesenchymal stem celltransplant mesenchymal stem cells for 3 times |
| mesenchymal stem cells enhanced treatment | Experimental | –transplant mesenchymal stem cells for 6 times |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed HIV infection, aged 18-65, both genders
- CD4+T count less than 500 cells/ul at baseline.
- No serious AIDS related events. 3. could understand and sign the informed consent form and comply with the requirements of this study.
- 4. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study
Key exclusion criteria (13 listed)
- have HBV/HCV/HDV/HEV infection, and the virological test is positive.
- The viral load for CMV and EBV is more than 1000 copies/ML.
- have HIV-2 infection.
- have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
- received treatment of hormones or other immunosuppressive drugs for a long time.
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 |
|---|---|---|
| mesenchymal stem cellAlso: umbilical cord derived MSCsMesenchymal stem cell dose is 0.75-1.0×10*6/kg and is transplanted by intravenous infusion. For the mesenchymal stem cell standard treatment group, the cells are used for three times(at week 0, 2,4 after recruitment) and the mesenchymal stem cell enhanced treatment group, the cells are used for six times(at week 0, 2,4,24,26,28 after recruitment). | Drug | mesenchymal stem cells standard treatment |
| salinesaline is used as placebo in the placebo comparator group | Other | placebo control |
Primary outcome
Number of participants with side effects in MSCs treatment groups
Time frame: 48 weeks
Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion.
CD4+ T cell counts after MSCs transfusion
Time frame: 48 weeks
at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline
1 secondary outcome
HIV RNA viral load
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Fu-Sheng Wang, Doctor principal investigator
Beijing 302 Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cell and saline in people with AIDS, run by Cell Energy Life Sciences Group Co. LTD at 4 sites 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu-Sheng Wang, Doctor (8610-13671005510, fswang302@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with side effects in MSCs treatment groups (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 12 Aug 2025.