A Phase 1/2 interventional study of adipose-derived multipotent mesenchymal stem cells in Mesenchymal Stromal Cells, Psoriasis and Drug Toxicity, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment
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Among 206 studies in Psoriasis with a site in China — 56 open to participants now, 66 under way, 22 of them phase 3. Psoriasis · China.
Among the 206 studies in Psoriasis with a site in China, this one is the 178th largest by enrollment of the 182 interventional ones that give a count, is one of 8 that started in 2017, is one of 11 in phase 1/2, and was the 28th registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →56 of the 206 studies in Psoriasis with a site in China are open now. Recruiting first, the newest first:
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18–55 · Healthy volunteers
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Guangdong Hengrui Pharmaceutical Co., Ltd · Sites in China
Ages 18+
Xijing Hospital · Sites in China
Ages 18–65
Zhejiang Wenda Pharma Technology LTD. · Sites in China
Ages 18–75 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
206 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 55 · Phase 3 60 · Phase 4 12
First in 2005; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 161 across the 182 interventional studies, 191 across the 24 observational. Of the 111 that completed or were terminated, 16 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
144 of 206 have an industry lead sponsor. The 10 most frequent:
Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Guangdong Provincial Hospital of Traditional Chinese Medicine has 7 studies filed under Psoriasis — fewer than ten, so there is no comparison to draw.
20 of the studies in Psoriasis with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07672561Phase 3Zhejiang Wenda Pharma Technology LTD.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis | 2026-11-30 |
| NCT07543224Phase 3Reistone Biopharma Company LimitedA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of RSS0393 Ointment in Adult Patients With Plaque Psoriasis. | 2027-01 |
| NCT07326813Phase 3InventisBio Co., LtdA Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis | 2027-07-12 |
| NCT07130604Phase 3InventisBio Co., LtdEvaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis | 2027-07-28 |
| NCT07724366Phase 3Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis | 2027-09 |
Add all 20 to your calendar (.ics) → With an account.
Among the 206 studies in Psoriasis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety and efficacy of Adipose-derived Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period, changes in PASI score and BSA, as well as DLQI.
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Numerous topical and systemic therapies are available for the treatment of psoriasis. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and biologic immune modifying agents are recommended, but all of them have some drawbacks or limitations. Until now, no curative treatment is available. Therefore, it is important to find new treatment for psoriasis.
Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into bone, cartilage and adipose cells. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were isolated from fat tissues and were reported to treat moderate to severe psoriasis vulgaris and psoriasis arthritis successfully by case reports. For the mechanism of the disease, involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells (MSCs) are found to have the function of immunomodulation, migration to skin lesions, limitation of autoimmunity. Therefore, investigators supposed that the injection of AD-MSCs could be beneficial for treatment of moderate to severe psoriasis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1．moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10% ) 2．18 to 65 years old 3．written/signed
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AD-MSCs（adipose-derived multipotent mesenchymal stem cells ） intravenous injection at a dose of 0.5 million cells/kg at week 0,week 4，week 8 with a duration for treatment for 12 weeks.
Biological: adipose-derived multipotent mesenchymal stem cells
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Also known as: AD-MSCs
Incidence of adverse events (AEs) related to intervention
The proportion of the adverse events related to intervention in the treatment group.
Time frame: 12 weeks (plus or minus 3 days) after treatment
Incidence of serious adverse events (SAEs) related to intervention
The proportion of the serious adverse events related to intervention in the treatment group.
Time frame: 12 weeks (plus or minus 3 days) after treatment
Improvement rate of PASI(Psoriasis Area and Severity Index)
The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline after treatment
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-50
The proportion of patients who achieve at least 50% improvement in PASI score from baseline.
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
Time frame: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Pruritus Scores on the Visual Analogue Scale
Time frame: 12 weeks (plus or minus 3 days) after treatment
BSA
the Body Surface Area
Time frame: 12 weeks (plus or minus 3 days) after treatment
DLQI（Dermatology Life Quality Index）
the Dermatology Life Quality Index
Time frame: 12 weeks (plus or minus 3 days) after treatment
Ran from Sep 2017 to primary completion in Aug 2019, 22 months.
Of 15 phase 1/2 interventional studies under Psoriasis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial Hospital of Traditional Chinese Medicine