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PsoriasisEarly Phase 1NCT03765957

Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells

A Early Phase 1 study testing Mesenchymal Stem Cells in people with Psoriasis, run by Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis
What is being tested?
Mesenchymal Stem Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
20 Feb 2019to 1 Jun 2021
Phase
Early Phase 1
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.Understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 Years to 65 Years old, Body Mass Index (BMI) between 18.5-35; 3.Diagnosed according to biopsy for Psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(body surface area)>10%, PGA≥3 and PASI>10 at baseline; 4. Patients participated in any stem cell therapy within 6 months;

Who cannot join

  • WBC(white blood cell count ) <3.5x109/L, blood platelet count<100x109/L, hemoglobin<100g/L serum creatinine>1.5 x ULN(upper limit of normal), bilirubin > 1.5 x ULN(upper limit of normal), AST(SGOT,glutamic-oxalacetic transaminase)/ALT(SGPT,glutamic-pyruvic transaminase) >2.0 x ULN(upper limit of normal);Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B virus-antibody ) or syphilis antibody is positive;
  • Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,Patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; Mental disorders, history of alcohol abuse, drug or other substance abuse;
  • Patients who have received systemic therapy within recent one month or topical therapy in two weeks;
  • Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs;
  • Pregnant women, or women who ready for pregnancy or lactating; Patients participated in any clinical trials within 3 months; Other cases which researchers believe that can not enroll.

Trial locations and contacts

1 site in 1 country.

Mi Zhang, M.D. Ph.D contact

08615116331788 ext. 08615116331788

648979182@qq.com

Yehong Kuang, M.D. Ph.D contact

08613574171102 ext. 08613574171102

yh_927@126.com

China1 site, 1 recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

    Mi Zhang, M.D. Ph.D, 08615116331788 ext. 08615116331788, 648979182@qq.com

    Yehong Kuang, M.D. Ph.D, 08613574171102 ext. 08613574171102, yh_927@126.com

    Recruiting

Other trials in China

About this study

To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel

Read the detailed description

Psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. Psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. In China, there are about 10 million psoriasis patients.

Human umbilical cord-derived MSC (huc-MSC) has many advantages for the treatment of immune disease. Because it was demonstrated that huc-MSCs are effective in modulating immune cells and treating diseases and it has low immunogenicity. Furthermore, huc-MSCs do not raise ethical issue for clinical applications.

Some experimental results and cases has showed that mesenchymal stem cell (MSC) can prevent or treat psoriasis. This clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.

Conditions
Psoriasis
Being tested
Mesenchymal Stem Cells
Keywords
Mesenchymal Stem Cells
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stem CellsBiological

    Also called Human Umbilical Cord-derived Mesenchymal Stem Cells

    After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjetcts of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. Besides MSCs, moisturizers such as boric acid ointment will be given to all subjects.

Study groups in NCT03765957
Study groupRoleWhat they receive
Mesenchymal Stem CellsExperimentalThe mesenchymal stem cells will be derived from human umbilical cord. After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjects of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment.
Receives: Biological: Mesenchymal Stem Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

    The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.

    Measured: Month 6

  2. Number of Participants Achieving a Physician Global Assessment (PGA) of (0, 1)

    The PGA is a physician's determination of the participant's psoriasis lesions overall categorized by descriptions for induration, erythema, and scaling.

    Measured: Month 6

Secondary outcomes (2)

  1. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

    The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

    Measured: Baseline, Month 6

  2. Adverse event

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start20 Feb 2019
  3. Primary completion31 Jul 2020
  4. Study completion1 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03765957
Sponsor's protocol ID
2018-MSC/CSU/PS
Status last verified
Sep 2020
First submitted
28 Aug 2018
Last updated
23 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Comella K, Parlo M, Daly R, Dominessy K. First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. Int Med Case Rep J. 2018 Mar 21;11:59-64. doi: 10.2147/IMCRJ.S163612. eCollection 2018.

    PubMed 29606893

  • Lee YS, Sah SK, Lee JH, Seo KW, Kang KS, Kim TY. Human umbilical cord blood-derived mesenchymal stem cells ameliorate psoriasis-like skin inflammation in mice. Biochem Biophys Rep. 2016 Oct 8;9:281-288. doi: 10.1016/j.bbrep.2016.10.002. eCollection 2017 Mar.

    PubMed 28956015

  • Boehncke WH, Schon MP. Psoriasis. Lancet. 2015 Sep 5;386(9997):983-94. doi: 10.1016/S0140-6736(14)61909-7. Epub 2015 May 27.

    PubMed 26025581

  • Owczarczyk-Saczonek A, Krajewska-Wlodarczyk M, Kruszewska A, Placek W, Maksymowicz W, Wojtkiewicz J. Stem Cells as Potential Candidates for Psoriasis Cell-Replacement Therapy. Int J Mol Sci. 2017 Oct 20;18(10):2182. doi: 10.3390/ijms18102182.

    PubMed 29053579

  • Guan LX, Guan H, Li HB, Ren CA, Liu L, Chu JJ, Dai LJ. Therapeutic efficacy of umbilical cord-derived mesenchymal stem cells in patients with type 2 diabetes. Exp Ther Med. 2015 May;9(5):1623-1630. doi: 10.3892/etm.2015.2339. Epub 2015 Mar 9.

    PubMed 26136869

  • Ra JC, Kang SK, Shin IS, Park HG, Joo SA, Kim JG, Kang BC, Lee YS, Nakama K, Piao M, Sohl B, Kurtz A. Stem cell treatment for patients with autoimmune disease by systemic infusion of culture-expanded autologous adipose tissue derived mesenchymal stem cells. J Transl Med. 2011 Oct 21;9:181. doi: 10.1186/1479-5876-9-181.

    PubMed 22017805

  • Dahbour S, Jamali F, Alhattab D, Al-Radaideh A, Ababneh O, Al-Ryalat N, Al-Bdour M, Hourani B, Msallam M, Rasheed M, Huneiti A, Bahou Y, Tarawneh E, Awidi A. Mesenchymal stem cells and conditioned media in the treatment of multiple sclerosis patients: Clinical, ophthalmological and radiological assessments of safety and efficacy. CNS Neurosci Ther. 2017 Nov;23(11):866-874. doi: 10.1111/cns.12759. Epub 2017 Sep 29.

    PubMed 28961381

  • Cui GH, Wang YY, Li CJ, Shi CH, Wang WS. Efficacy of mesenchymal stem cells in treating patients with osteoarthritis of the knee: A meta-analysis. Exp Ther Med. 2016 Nov;12(5):3390-3400. doi: 10.3892/etm.2016.3791. Epub 2016 Oct 11.

    PubMed 27882169

  • Cheng L, Wang S, Peng C, Zou X, Yang C, Mei H, Li C, Su X, Xiao N, Ouyang Q, Zhang M, Wang Q, Luo Y, Shen M, Qin Q, Wang H, Zhu W, Lu G, Lin G, Kuang Y, Chen X. Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study. Signal Transduct Target Ther. 2022 Aug 5;7(1):263. doi: 10.1038/s41392-022-01059-y.

    PubMed 35927231

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mesenchymal Stem Cells in people with Psoriasis, run by Central South University 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 5 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 23 Sep 2020. 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Mi Zhang, M.D. Ph.D (08615116331788 ext. 08615116331788, 648979182@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (time frame: Month 6). 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?

On the ClinicalTrials.gov record for NCT03765957, which also lists 9 linked publications.

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 23 Sep 2020.

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