Psoriasis VulgarisPhase 1/2NCT02491658
Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris
A Phase 1/2 study testing UC-MSCs in people with Psoriasis Vulgaris, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2016
- 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
- Diagnosis of stable psoriasis vulgaris for at least 6 months
- Baseline Psoriasis Area and Severity Index (PASI) score >= 8
- Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
- No other psoriasis management (topical or systemic) during the UC-MSCs infusions
- Willing and able to comply with all study requirements and provide informed consent
Who cannot join
- Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
- With other disease
- Systemic treatments within 4 weeks before the baseline visit
- Topical treatment within 2 weeks before the baseline visit
- Uncontrolled active infections
- Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
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- History of severe systemic disease or malignancy
- Pregnant or lactating females, or willing to have a baby in the next year
- Cannot be traced on time
- Any other situations not suitable for this study determined by the investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Hu Chen, Ph.D, +86-010-6694-7108, chenhu217@aliyun.com
Bin Zhang, Ph.D, +86-010-6694-7125, zb307ctc@163.com
About this study
Official title: A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris
The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.
Read the detailed description
Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.
Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.
In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.
- Conditions
- Psoriasis Vulgaris
- Being tested
- UC-MSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
Also called umbilical cord derived mesenchymal stem cells
Psoriasis Vulgaris patients will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks, then the last two times will be given once every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treat Psoriasis Vulgaris with UC-MSCs | Experimental | Subjects in this arm will receive 6 times UC-MSCs infusions (each time 1×10^6/kg) within 8 weeks. Receives: Biological: UC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks
PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
Measured: baseline and 8 weeks
Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks
DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
Measured: baseline and 8 weeks
Secondary outcomes (4)
body temperature will be monitored for any possible infusion-related toxicities.
Measured: up to 3 months
blood pressure will be monitored for any possible infusion-related toxicities.
Measured: up to 3 months
Psoriasis Area and Severity Index (PASI) score
PASI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
Measured: month 6, 9, and 12
Dermatology Life Quality Index (DLQI) score
DLQI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
Measured: month 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Hu, Ph.D, Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491658
- Sponsor's protocol ID
- 307-PV-MSC
- Status last verified
- Jul 2015
- First submitted
- 24 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02491658
- Acronym / sponsor ID
- 307-PV-MSC
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- 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 investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.
Detailed description
Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.
Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.
In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treat Psoriasis Vulgaris with UC-MSCs | Experimental | Biological: UC-MSCsSubjects in this arm will receive 6 times UC-MSCs infusions (each time 1×10^6/kg) within 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stable psoriasis vulgaris for at least 6 months
- Baseline Psoriasis Area and Severity Index (PASI) score >= 8
- Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
- No other psoriasis management (topical or systemic) during the UC-MSCs infusions
- Willing and able to comply with all study requirements and provide informed consent
Key exclusion criteria (10 listed)
- Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
- With other disease
- Systemic treatments within 4 weeks before the baseline visit
- Topical treatment within 2 weeks before the baseline visit
- Uncontrolled active infections
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 |
|---|---|---|
| UC-MSCsAlso: umbilical cord derived mesenchymal stem cellsPsoriasis Vulgaris patients will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks, then the last two times will be given once every two weeks. | Biological | Treat Psoriasis Vulgaris with UC-MSCs |
Primary outcome
Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks
Time frame: baseline and 8 weeks
PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks
Time frame: baseline and 8 weeks
DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
4 secondary outcomes
body temperature will be monitored for any possible infusion-related toxicities.
Time frame: up to 3 months
blood pressure will be monitored for any possible infusion-related toxicities.
Time frame: up to 3 months
Psoriasis Area and Severity Index (PASI) score
Time frame: month 6, 9, and 12
Dermatology Life Quality Index (DLQI) score
Time frame: month 6, 9, and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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.
Chen Hu, Ph.D principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
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 UC-MSCs in people with Psoriasis Vulgaris, run by Affiliated Hospital to Academy of Military Medical Sciences 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 5 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 8 Jul 2015. 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 Chen Hu, Ph.D. (+86-010-6694-7108, chenhu217@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks (time frame: baseline and 8 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 8 Jul 2015.