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Primary Biliary CholangitisPhase 1/2MSC-PBC-I/IINCT07795151

Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis

A Phase 1/2 study testing Standard background therapy, hUC-MSC Dose Level 1 and hUC-MSC Dose Level 2 in people with Primary Biliary Cholangitis, run by Beijing 302 Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I/II clinical trial evaluates human umbilical cord-derived mesenchymal stromal cell (hUC-MSC) injection in patients with primary biliary cholangitis (PBC). The phase I component uses a 3+3 dose-escalation design with separate single-dose and multiple-dose stages to assess safety and tolerability, establish… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Biliary Cholangitis
What is being tested?
Standard background therapy, hUC-MSC Dose Level 1 and hUC-MSC Dose Level 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteChina
Study dates
31 Aug 2026to 31 Aug 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation and signed informed consent.
  • Age 18 to 75 years, both genders.
  • Diagnosis of PBC per the 2025 PBC Guideline of the National Health Commission of China, meeting at least 2 of the following 3 criteria:
  • Biochemical evidence of cholestasis (predominantly elevated ALP and GGT) with imaging excluding extrahepatic or intrahepatic large bile duct obstruction;
  • Positive for anti-mitochondrial antibody (AMA)/AMA-M2, or other PBC-specific autoantibodies (anti-gp210, anti-sp100);
  • Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
Show all 11Show fewer
  • Inadequate response to UDCA prior to enrollment, defined as ALP ≥1.67×ULN after at least 6 months of UDCA therapy (with stable dose for ≥3 months before screening).
  • 1.67×ULN ≤ ALP < 10×ULN and total bilirubin ≤ 3×ULN at screening.
  • If taking colchicine, stable dose for ≥3 months before screening.
  • If taking medications for pruritus (e.g., cholestyramine, rifampicin, naltrexone, sertraline), stable dose for ≥3 months before screening.
  • If taking statins or ezetimibe, stable dose for ≥2 months before screening.

Who cannot join

  • Concurrent or previous other liver diseases, including but not limited to: chronic hepatitis B, chronic hepatitis C, primary sclerosing cholangitis (PSC), complete biliary obstruction, alcoholic liver disease, autoimmune hepatitis or overlap with other autoimmune liver diseases, non-alcoholic steatohepatitis (NASH), suspected or confirmed Gilbert's syndrome.
  • Decompensated cirrhosis (defined as presence of at least one of: esophageal/gastric variceal bleeding, hepatic encephalopathy, ascites, hepatorenal syndrome) based on clinical, laboratory, imaging, or histopathological findings.
  • Any of the following laboratory abnormalities at screening: creatinine ≥1.5×ULN or creatinine clearance <60 mL/min; ALT and/or AST >5×ULN; albumin <30 g/L; creatine kinase >2×ULN; platelet count < lower limit of normal; INR ≥1.5 or prothrombin activity ≤40%.
  • Diseases that may cause non-hepatic elevation of alkaline phosphatase (e.g., Paget's disease).
  • Use of prohibited medications within specified washout periods:
  • Within 2 months before screening: fibrates and glitazones;
Show all 17Show fewer
  • Within 3 months before screening: obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline, budesonide and other systemic corticosteroids by long-term parenteral or oral administration only, and hepatotoxic drugs (e.g., α-methyldopa, valproate, isoniazid, nitrofurantoin);
  • Within 12 months before screening: antibodies or immunotherapies targeting interleukins or other cytokines/chemokines.
  • Uncontrolled cardiovascular, digestive, respiratory, urinary, neurological, psychiatric disorders (including substance/alcohol abuse), immunodeficiency, or severe autoimmune diseases, or any condition that may limit life expectancy to <2 years, or judged by the investigator as unsuitable for participation.
  • History of malignancy within the past 2 years (except localized squamous cell carcinoma of skin or treated cervical intraepithelial neoplasia), regardless of treatment or evidence of local recurrence/metastasis.
  • Received any other investigational drug or participated in another interventional clinical trial within 3 months before screening; prior use of elafibranor or seladelpar.
  • History of drug or alcohol abuse within 1 year before screening.
  • Pregnant, planning pregnancy, or women of childbearing potential unwilling to use effective contraception (≥1 method) during the study and for 30 days after last dose; breastfeeding women.
  • Co-infection with HIV or syphilis.
  • Known allergy to any component of the study drug.
  • Psychologically unstable or incapacitated, unable to provide valid informed consent or comply with study procedures.
  • Any other condition judged by the investigator as unsuitable for enrollment, or that may interfere with the analysis of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Shi, MD, PhD contact

86-10-66949623

shilei302@126.com

Fu-Sheng Wang, MD, PhD contact

86-10-66933332

fswang302@163.com

China1 site

  • Beijing 302 Hospital

    Beijing, Beijing Municipality

    Lei Shi, MD, PhD, 86-10-66949623, shilei302@126.com

Other trials in China

About this study

Official title: A Phase I/II Clinical Study of Human Umbilical Cord-Derived Mesenchymal Stromal Cells in the Treatment of Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid

This phase I/II clinical trial evaluates human umbilical cord-derived mesenchymal stromal cell (hUC-MSC) injection in patients with primary biliary cholangitis (PBC). The phase I component uses a 3+3 dose-escalation design with separate single-dose and multiple-dose stages to assess safety and tolerability, establish the maximum tolerated dose and recommended phase II dose, while monitoring adverse events, vital signs, laboratory parameters, and immunogenicity, and to explore preliminary efficacy signals. The phase II component is a randomized, double-blind, placebo-controlled trial with the primary endpoint of composite response of alkaline phosphatase and bilirubin at 12 weeks to evaluate efficacy, alongside continuous safety surveillance. Systematic measurements of liver function, cholestasis, immune markers, quality of life, and pruritus scores are incorporated to investigate mechanisms and potential biomarkers, aiming to generate robust clinical evidence that supports future development and clinical translation of hUC-MSC therapy for PBC.

Read the detailed description

This is a phase I/II clinical trial. The phase I component uses a conventional "3+3" dose-escalation design with three dose levels: low (1.0×10⁸ cells), medium (1.5×10⁸ cells), and high (2.0×10⁸ cells). Each dose cohort enrolls 3-6 evaluable participants, for a total of 18-36 evaluable subjects. Phase Ia is a single-dose stage, with dose-limiting toxicity (DLT) assessed up to 7 days after the infusion. Phase Ib is a multiple-dose stage, in which participants receive one intravenous infusion weekly for 3 consecutive weeks, and DLT is evaluated up to 28 days after the first dose. The aim is to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D).

The phase II component plans to enroll 50 patients with primary biliary cholangitis, who will be randomized in a 2:2:1 ratio to receive either dose level 1 (1.5×10⁸ cells), dose level 2 (2.0×10⁸ cells), or placebo control, with the final dose to be confirmed based on the results of phase I. The treatment regimen consists of one intravenous infusion weekly for 3 consecutive weeks. The primary objective of phase II is to evaluate preliminary efficacy.

Being tested
Standard background therapy, Placebo, hUC-MSC Dose Level 1, hUC-MSC Dose Level 2
Medical subject headings
Liver Cirrhosis, Biliary

What participants receive

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

  • Standard background therapyDrug

    UDCA capsule 250 mg, orally, 13-15 mg/kg/day, taken with a small amount of water. This background therapy is administered only to participants who have been on a stable dose of UDCA for at least 6 months prior to enrollment (and stable for ≥3 months before screening). Participants who are intolerant to UDCA (and have not used UDCA for ≥3 months before enrollment) do not receive UDCA during the study.

  • PlaceboDrug

    Matching placebo solution (e.g., 5% human serum albumin in 0.9% saline) administered via peripheral intravenous infusion at Week 0, Week 1, and Week 2 (once weekly for 3 infusions).

  • hUC-MSC Dose Level 1Biological

    Human umbilical cord-derived mesenchymal stromal cells, planned at 1.5×10⁸ cells per infusion (final dose subject to confirmation based on phase I MTD/RP2D). Administered via peripheral intravenous infusion at Week 0, Week 1, and Week 2 (once weekly for 3 infusions).

  • hUC-MSC Dose Level 2Biological

    Human umbilical cord-derived mesenchymal stromal cells, planned at 2.0×10⁸ cells per infusion (final dose subject to confirmation based on phase I MTD/RP2D). Administered via peripheral intravenous infusion at Week 0, Week 1, and Week 2 (once weekly for 3 infusions).

Study groups in NCT07795151
Study groupRoleWhat they receive
Placebo GroupPlacebo comparatorParticipants receive placebo infusions via peripheral intravenous infusion once weekly for 3 consecutive weeks (at Week 0, Week 1, and Week 2), in addition to background therapy as per inclusion criteria (i.e., continued stable UDCA for patients on prior UDCA, or no UDCA for those intolerant to UDCA).
Receives: Drug: Standard background therapy; Drug: Placebo
hUC-MSC Dose Level 1 (planned 1.5×10⁸ cells, final dose TBD)ExperimentalParticipants receive human umbilical cord-derived mesenchymal stromal cells (hUC-MSC) at a planned dose of 1.5×10⁸ cells per infusion (final dose to be confirmed based on the maximum tolerated dose / recommended phase II dose determined from phase I results) via peripheral intravenous infusion once weekly for 3 consecutive weeks (at Week 0, Week 1, and Week 2), in addition to background therapy as per inclusion criteria (continued stable UDCA for prior users, or no UDCA for intolerant patients).
Receives: Drug: Standard background therapy; Biological: hUC-MSC Dose Level 1
hUC-MSC Dose Level 2 (planned 2.0×10⁸ cells, final dose TBD)ExperimentalParticipants receive hUC-MSC at a planned dose of 2.0×10⁸ cells per infusion (final dose to be confirmed based on the MTD/RP2D from phase I) via peripheral intravenous infusion once weekly for 3 consecutive weeks (at Week 0, Week 1, and Week 2), in addition to background therapy as per inclusion criteria (continued stable UDCA for prior users, or no UDCA for intolerant patients).
Receives: Drug: Standard background therapy; Biological: hUC-MSC Dose Level 2

What is being measured

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

  1. Incidence of Dose-Limiting Toxicity (DLT) in Phase I

    Occurrence of DLT during the DLT observation period (single-dose cohort: 7 days after infusion; multiple-dose cohort: 28 days after first infusion), graded by CTCAE v6.0.

    Measured: Up to Day 7 (single-dose) or up to Day 28 (multiple-dose).

  2. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events (Phase I)

    Safety and tolerability assessed by monitoring TEAEs, SAEs, and clinically significant changes in vital signs, physical examination, laboratory parameters, and 12-lead ECG.

    Measured: Up to Day 7 (single-dose) or up to Day 28 (multiple-dose).

  3. Maximum Tolerated Dose (MTD) of hUC-MSC in PBC Patients (Phase I)

    Determination of MTD based on DLT occurrence in the 3+3 dose-escalation phase I; MTD is the highest dose with ≤1/6 participants experiencing DLT.

    Measured: At completion of phase I dose escalation (after DLT evaluation).

  4. Composite Biochemical Response at Week 12 (Phase II)

    Proportion of participants achieving all three: ALP < 1.67×ULN, ALP reduction ≥15% from baseline, and total bilirubin ≤ ULN at Week 12.

    Measured: Week 12

Secondary outcomes (23)

  1. Proportion with ALP <1.67×ULN or ALP Reduction ≥15% or TB ≤ULN at Week 12 (Phase I)

    Exploratory efficacy endpoint for phase I - participants meeting at least one of the three criteria at Week 12.

    Measured: Week 12

  2. Change from Baseline in Alkaline Phosphatase (ALP) (Phase I)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  3. Change from Baseline in Total Bilirubin (TB) (Phase I)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  4. Change from Baseline in Direct Bilirubin (DBIL) (Phase I)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  5. Change from Baseline in Alanine Aminotransferase (ALT) (Phase I)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  6. Change from Baseline in Aspartate Aminotransferase (AST) (Phase I)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  7. Change from Baseline in Gamma-Glutamyl Transferase (GGT) (Phase I)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  8. Change from Baseline in Primary Biliary Cholangitis-40 (PBC-40) Total Score (Phase I)

    Scale range: 40-200; higher scores indicate worse disease-specific quality of life.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  9. Change from Baseline in Pruritus Numerical Rating Scale (NRS) Score (Phase I)

    Scale range: 0-10; higher scores indicate worse itch severity.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  10. Change from Baseline in Itchy Quality of Life (ItchyQoL) Total Score (Phase I)

    Scale range: 22-110; higher scores indicate worse itch-related quality of life.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  11. Change from Baseline in Alkaline Phosphatase (ALP) (Phase II)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  12. Change from Baseline in Total Bilirubin (TB) (Phase II)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  13. Change from Baseline in Direct Bilirubin (DBIL) (Phase II)

    Absolute and percentage changes from baseline at each specified visit.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  14. Change from Baseline in Alanine Aminotransferase (ALT) (Phase II)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  15. Change from Baseline in Aspartate Aminotransferase (AST) (Phase II)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  16. Change from Baseline in Gamma-Glutamyl Transferase (GGT) (Phase II)

    Absolute and percentage changes from baseline.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  17. Change from Baseline in Primary Biliary Cholangitis-40 (PBC-40) Total Score (Phase II)

    Scale range: 40-200; higher scores indicate worse disease-specific quality of life.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  18. Change from Baseline in Pruritus Numerical Rating Scale (NRS) Score (Phase II)

    Scale range: 0-10; higher scores indicate worse itch severity.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  19. Change from Baseline in Itchy Quality of Life (ItchyQoL) Total Score (Phase II)

    Scale range: 22-110; higher scores indicate worse itch-related quality of life.

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96

  20. Change from Baseline in Serum Total Bile Acids (TBA) (Phase II)

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  21. Change from Baseline in 7α-Hydroxy-4-cholesten-3-one (C4) (Phase II)

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  22. Change from Baseline in Fibroblast Growth Factor 19 (FGF-19) (Phase II)

    Measured: Baseline, Day 3, Week 1, 2, 4, 12, 24, 48, 72, 96.

  23. Change from Baseline in Liver Stiffness by Transient Elastography (Phase II)

    Change in liver stiffness measurement (kPa) at Week 12.

    Measured: Baseline and Week 12.

Timeline

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

  1. First posted31 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2030 (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
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The phase I dose-escalation stage (3+3 design) is conducted first to determine the recommended phase II dose; after that, the phase II randomized, double-blind, placebo-controlled stage is initiated with three parallel arms.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795151
Sponsor's protocol ID
KY-2026-7-120-1
Acronym
MSC-PBC-I/II
Status last verified
May 2026
First submitted
24 Aug 2026
Last updated
31 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After approval from the steering committee and the Human Genetic ResourcesAdministration of China, this trial data can be shared with qualifying researchers whosubmit a proposal with a valuable research question. A contract should be signed.

Publications

  • Phang MWL, Hisam NSM, Supandi F, Cheng PG, Lim SH, Lim LW, Wong KH. The Tiger Milk Medicinal Mushroom Lignosus rhinocerus (Agaricomycetes) Mitigates Oxidative Damage in a Cellular Model Mimicking Friedreich's Ataxia. Int J Med Mushrooms. 2025;27(11):63-87. doi: 10.1615/IntJMedMushrooms.2025059734.

    PubMed 40752029

  • Chen W, Lin F, Feng X, Yao Q, Yu Y, Gao F, Zhou J, Pan Q, Wu J, Yang J, Yu J, Cao H, Li L. MSC-derived exosomes attenuate hepatic fibrosis in primary sclerosing cholangitis through inhibition of Th17 differentiation. Asian J Pharm Sci. 2024 Feb;19(1):100889. doi: 10.1016/j.ajps.2024.100889. Epub 2024 Feb 12.

    PubMed 38419761

  • Zheng X, Tian S, Li T, Zhang S, Zhou X, Liu Y, Su R, Zhang M, Li B, Qi C, Guo G, Ma S, Sun K, Yang F, Hu Y, Yang C, Cui L, Shang Y, Guo C, Jin B, Guan L, Wang J, Ning W, Han Y. Host FSTL1 defines the impact of stem cell therapy on liver fibrosis by potentiating the early recruitment of inflammatory macrophages. Signal Transduct Target Ther. 2025 Mar 7;10(1):81. doi: 10.1038/s41392-025-02162-6.

    PubMed 40050288

  • Ye Y, Zhang X, Su D, Ren Y, Cheng F, Yao Y, Shi G, Ji Y, Chen S, Shi P, Dai L, Su X, Deng H. Therapeutic efficacy of human adipose mesenchymal stem cells in Crohn's colon fibrosis is improved by IFN-gamma and kynurenic acid priming through indoleamine 2,3-dioxygenase-1 signaling. Stem Cell Res Ther. 2022 Sep 8;13(1):465. doi: 10.1186/s13287-022-03157-8.

    PubMed 36076306

  • Wang L, Han Q, Chen H, Wang K, Shan GL, Kong F, Yang YJ, Li YZ, Zhang X, Dong F, Wang Q, Xu D, Hu ZJ, Wang SH, Keating A, Bi YL, Zhang FC, Zhao RC. Allogeneic bone marrow mesenchymal stem cell transplantation in patients with UDCA-resistant primary biliary cirrhosis. Stem Cells Dev. 2014 Oct 15;23(20):2482-9. doi: 10.1089/scd.2013.0500. Epub 2014 Jul 16.

    PubMed 24835895

  • Shokati A, Nikbakht M, Sahraian MA, Saeedi R, Asadollahzadeh E, Rezaeimanesh N, Chahardouli B, Gharaylou Z, Mousavi SA, Ai J, Naser Moghadasi A. Cell therapy with placenta-derived mesenchymal stem cells for secondary progressive multiple sclerosis patients in a phase 1 clinical trial. Sci Rep. 2025 May 8;15(1):16005. doi: 10.1038/s41598-025-00590-6.

    PubMed 40341605

  • Shi L, Zhang Z, Mei S, Wang Z, Xu Z, Yao W, Liu L, Yuan M, Pan Y, Zhu K, Liu K, Meng F, Sun J, Liu W, Xie X, Dong T, Huang L, Meng F, Fu JL, Li Y, Zhang C, Fan X, Shi M, Zhang Y, Li Y, Xie WF, Zhang P, Wang FS. Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights. Signal Transduct Target Ther. 2025 Jul 29;10(1):238. doi: 10.1038/s41392-025-02318-4.

    PubMed 40721581

  • Li L, He Y, Zhao J, Yin H, Feng X, Fan X, Wu W, Lu Q. Mesenchymal Stromal Cell-Based Therapy: A Promising Approach for Autoimmune Diseases. Clin Rev Allergy Immunol. 2025 Feb 21;68(1):21. doi: 10.1007/s12016-025-09030-9.

    PubMed 39982546

  • Hoang DM, Pham PT, Bach TQ, Ngo ATL, Nguyen QT, Phan TTK, Nguyen GH, Le PTT, Hoang VT, Forsyth NR, Heke M, Nguyen LT. Stem cell-based therapy for human diseases. Signal Transduct Target Ther. 2022 Aug 6;7(1):272. doi: 10.1038/s41392-022-01134-4.

    PubMed 35933430

  • Gholamrezanezhad A, Mirpour S, Bagheri M, Mohamadnejad M, Alimoghaddam K, Abdolahzadeh L, Saghari M, Malekzadeh R. In vivo tracking of 111In-oxine labeled mesenchymal stem cells following infusion in patients with advanced cirrhosis. Nucl Med Biol. 2011 Oct;38(7):961-7. doi: 10.1016/j.nucmedbio.2011.03.008. Epub 2011 Jun 22.

    PubMed 21810549

  • Wang Y, Chen X, Cao W, Shi Y. Plasticity of mesenchymal stem cells in immunomodulation: pathological and therapeutic implications. Nat Immunol. 2014 Nov;15(11):1009-16. doi: 10.1038/ni.3002.

    PubMed 25329189

  • Ankrum JA, Ong JF, Karp JM. Mesenchymal stem cells: immune evasive, not immune privileged. Nat Biotechnol. 2014 Mar;32(3):252-60. doi: 10.1038/nbt.2816. Epub 2014 Feb 23.

    PubMed 24561556

  • Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143.

    PubMed 10102814

  • Galipeau J, Sensebe L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018 Jun 1;22(6):824-833. doi: 10.1016/j.stem.2018.05.004.

    PubMed 29859173

  • You H, Ma X, Efe C, Wang G, Jeong SH, Abe K, Duan W, Chen S, Kong Y, Zhang D, Wei L, Wang FS, Lin HC, Yang JM, Tanwandee T, Gani RA, Payawal DA, Sharma BC, Hou J, Yokosuka O, Dokmeci AK, Crawford D, Kao JH, Piratvisuth T, Suh DJ, Lesmana LA, Sollano J, Lau G, Sarin SK, Omata M, Tanaka A, Jia J. APASL clinical practice guidance: the diagnosis and management of patients with primary biliary cholangitis. Hepatol Int. 2022 Feb;16(1):1-23. doi: 10.1007/s12072-021-10276-6. Epub 2022 Feb 4. No abstract available.

    PubMed 35119627

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Standard background therapy, hUC-MSC Dose Level 1 and hUC-MSC Dose Level 2 in people with Primary Biliary Cholangitis, run by Beijing 302 Hospital 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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 31 Aug 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Shi, MD, PhD (86-10-66949623, shilei302@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicity (DLT) in Phase I (time frame: Up to Day 7 (single-dose) or up to Day 28 (multiple-dose).). The study lists 4 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 NCT07795151, which also lists 18 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 31 Aug 2026.

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