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

NCT03765957 | Unknown Early Phase 1 DMC

• 1 other identifier: 2018-MSC/CSU/PS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Keywords

Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (2)

• 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.

  Month 6

• 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.

  Month 6

Secondary Outcomes (2)

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

  Baseline, Month 6

• Adverse event

  Baseline, Month 6

Study Arms (1)

Mesenchymal Stem Cells

EXPERIMENTAL

The 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.

Biological: Mesenchymal Stem Cells

Interventions

Mesenchymal Stem Cells BIOLOGICAL

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.

Also known as: Human Umbilical Cord-derived Mesenchymal Stem Cells

Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 29606893 BACKGROUND

• 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.

  PMID: 28956015 BACKGROUND

• 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.

  PMID: 26025581 BACKGROUND

• 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.

  PMID: 29053579 BACKGROUND

• 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.

  PMID: 26136869 BACKGROUND

• 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.

  PMID: 22017805 BACKGROUND

• 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.

  PMID: 28961381 BACKGROUND

• 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.

  PMID: 27882169 BACKGROUND

• 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.

  PMID: 35927231 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiang Chen, M.D. Ph.D

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Zhang, M.D. Ph.D

CONTACT

08615116331788; 648979182@qq.com

Yehong Kuang, M.D. Ph.D

CONTACT

08613574171102; yh_927@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: December 5, 2018
• Study Start: February 20, 2019
• Primary Completion: July 31, 2020
• Study Completion: June 1, 2021
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

CN (1)