Health TrialsbyHealthPanel

Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

ConditionAIDS
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCell Energy Life Sciences Group Co. LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mesenchymal stem cell

    Drug

    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).

  • saline

    Other intervention

    saline is used as placebo in the placebo comparator group

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: placebo controlPlacebo comparator 1 intervention
Group B: mesenchymal stem cells standard treatmentExperimental treatment 1 intervention
Group C: mesenchymal stem cells enhanced treatmentExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
48 weeks
2

CD4+ T cell counts after MSCs transfusion

at week 12, 24 and 48, evaluate CD4+ T cell counts and compare with baseline

Time frame
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.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cell Energy Life Sciences Group Co. LTD

Lead sponsor

Beijing 302 Hospital

Collaborator

Shenzhen Third People's Hospital

Collaborator

Fifth Hospital of Shijiazhuang City

Collaborator

Beijing YouAn Hospital

Collaborator

Source ClinicalTrials.gov
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