Mesenchymal Stromal CellsPhase 1/2UCMSCsNCT03745417
Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis
A Phase 1/2 study testing Umbilical cord mesenchymal stem cells in people with Mesenchymal Stromal Cells and Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis. Any adverse events related to UCMSCs infusion will be monitored.The primary outcome is the improvement rate of PASI(Psoriasis Area and Severity Index) and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect
- What is being tested?
- Umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2021to 31 Dec 2022
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1．moderate to severe psoriasis vulgaris ( PASI > 7 or BSA >10% ) 2．18 to 65 years old 3．written/signed informed consent
Who cannot join
- guttate psoriasis, inverse psoriasis or exclusively associated with the face
- Acute progressive psoriasis, and erythroderma tendency
- current (or within 1 year) pregnancy or lactation
- current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) > 50 or the Self-rating Depression Scale (SDS) > 53, or with other psychiatric disorders
- With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ > 2.9 mmol/L or < 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
- Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
Show all 10Show fewer
- allergy to anything else ever before;
- current registration in other clinical trials or participation within a month;
- topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
- medical conditions assessed by investigators, that are not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Chuanjian Lu, PhD, (8620)81887233 ext. 31223, luchuanjian888@vip.sina.com
Zehuai Wen, PhD, （86）13903008091, wenzehuai@139.com
About this study
Official title: Efficacy and Safety of Expanded Umbilical Cord Mesenchymal Stem Cells On Patients With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis. Any adverse events related to UCMSCs infusion will be monitored.The primary outcome is the improvement rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after UCMSCs infusion.
Read the detailed description
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. Umbilical cord Mesenchymal Stem Cells were isolated from umbilical cord matrix 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 UCMSCs could be beneficial for treatment of moderate to severe psoriasis.
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Being tested
- Umbilical cord mesenchymal stem cells
- Keywords
- Psoriasis, Umbilical cord Mesenchymal Stem Cells
- Medical subject headings
- Psoriasis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord mesenchymal stem cellsBiological
Also called UCMSCs
Umbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs group | Experimental | Umbilical cord mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg at week 0,week 2,week 4,week 6,week 8 with a duration for treatment for 12 weeks. Receives: Biological: Umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI score improvement rate
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
Measured: 12 weeks (plus or minus 3 days) after treatment
Secondary outcomes (7)
Psoriasis Area and Severity Index(PASI)
The improvement in PASI score from baseline after treatment. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
Measured: 12 weeks (plus or minus 3 days) after treatment
Relapse rate in treatment period / follow-up period
Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.
Measured: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
PASI-50
The proportion of patients who achieve at least 50% improvement in PASI score from baseline. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
Measured: 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. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72.
Measured: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Pruritus Scores on the Visual Analogue Scale
Measured: 12 weeks (plus or minus 3 days) after treatment
the Body Surface Area (BSA%)
the Body Surface Area
Measured: 12 weeks (plus or minus 3 days) after treatment
the Dermatology Life Quality Index（DLQI）
the score of Dermatology Life Quality Index. Dermatology Life Quality Index (DLQI) is a self-administered 10-item questionnaire. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, and Treatment.
Measured: 12 weeks (plus or minus 3 days) after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start31 Aug 2021 (estimated)
- Primary completion28 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stromal CellsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745417
- Sponsor's protocol ID
- S2018-11
- Acronym
- UCMSCs
- Status last verified
- Jan 2021
- First submitted
- 15 Nov 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Expanded Umbilical Cord Mesenchymal Stem Cells On Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT03745417
- Acronym / sponsor ID
- UCMSCs / S2018-11
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Keywords
- Psoriasis, Umbilical cord Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 28 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Nov 2018 (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 purpose of this study is to evaluate the efficacy and safety of Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis. Any adverse events related to UCMSCs infusion will be monitored.The primary outcome is the improvement rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after UCMSCs infusion.
Detailed description
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. Umbilical cord Mesenchymal Stem Cells were isolated from umbilical cord matrix 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 UCMSCs could be beneficial for treatment of moderate to severe psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCMSCs group | Experimental | Biological: Umbilical cord mesenchymal stem cellsUmbilical cord mesenchymal stem cells intravenous injection at a dose of 2 million cells/kg at week 0,week 2,week 4,week 6,week 8 with a duration for treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1．moderate to severe psoriasis vulgaris ( PASI > 7 or BSA >10% ) 2．18 to 65 years old 3．written/signed informed consent
Key exclusion criteria (10 listed)
- guttate psoriasis, inverse psoriasis or exclusively associated with the face
- Acute progressive psoriasis, and erythroderma tendency
- current (or within 1 year) pregnancy or lactation
- current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) > 50 or the Self-rating Depression Scale (SDS) > 53, or with other psychiatric disorders
- With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ > 2.9 mmol/L or < 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
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 |
|---|---|---|
| Umbilical cord mesenchymal stem cellsAlso: UCMSCsUmbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg. | Biological | UCMSCs group |
Primary outcome
PASI score improvement rate
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100%
7 secondary outcomes
Psoriasis Area and Severity Index(PASI)
Time frame: 12 weeks (plus or minus 3 days) after treatment
Relapse rate in treatment period / follow-up period
Time frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
PASI-50
Time frame: 12 weeks (plus or minus 3 days) after treatment
PASI-75
Time frame: 12 weeks (plus or minus 3 days) after treatment
Pruritus Scores on the Visual Analogue Scale
Time frame: 12 weeks (plus or minus 3 days) after treatment
the Body Surface Area (BSA%)
Time frame: 12 weeks (plus or minus 3 days) after treatment
the Dermatology Life Quality Index（DLQI）
Time frame: 12 weeks (plus or minus 3 days) after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Related trials for Mesenchymal Stromal Cells
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 1
ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 1/2
Stem Cell Therapy for Intracerebral Hemorrhage
Intracerebral Hemorrhage, Mesenchymal Stem Cell
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.
1 site 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 Umbilical cord mesenchymal stem cells in people with Mesenchymal Stromal Cells and Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 1 inclusion and 10 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 9 Feb 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanjian Lu, PhD (+8620-81887233-31223, luchuanjian888@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI score improvement rate (time frame: 12 weeks (plus or minus 3 days) after treatment). 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 9 Feb 2021.