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Status unknownNCT05160831Updated Dec 16, 2021

Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis

An interventional study of Human umbilical cord mesenchymal stem cells in Knee Osteoarthritis, sponsored by Southwest Hospital, China. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.

Read the detailed description

There are more than 100 types of arthritis, and the most common ones are rheumatoid arthritis (RA) and osteoarthritis (OA). The main cause of its pathogenesis is the compensatory hyperplasia of the articular cartilage caused by the body's degenerative changes, which will eventually cause the joint to partially or completely lose its function.

In the past few decades, continuous efforts have been made to treat OA. The treatment of OA changes with the development of the patient's condition. At present, there are many diagnosis and treatment options for knee OA, including conservative treatment and surgical treatment. There is an urgent need for an effective treatment to postpone or terminate the course of OA.

Cell therapy for OA has developed rapidly in recent years and has received widespread attention. Mesenchymal stem cells (MSCs) are pluripotent stem cells with potential of self-renewal, proliferation and differentiation. Stem cells are extracted from the patient's body and then implanted back. Their ability of regeneration and reproduction can fill the damaged cartilage tissue, so as to achieve an effective treatment of the joint damage.

This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee joint
  • osteoarthritis
  • human umbilical cord mesenchymal stem cells
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who have no major organ dysfunction.
  • Diagnosed as moderate to severe knee osteoarthritis according to internationally recognized criteria: a). Meets the criteria of the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" revised by the Chinese Medical Association Rheumatology Branch in 2018; b). Meets the criteria of Grade 3 or more according to the American College of Rheumatology (ACR); c).Meets the criteria of Grade Ⅲ or more according to Kellgren-Lawrence's OA radiology grading standard.
  • Those who have the ability to move independently, except those who use wheelchairs, walkers or crutches, and who have no history of mental illness.
  • There is no obvious contraindication to articular cavity injection in hematology and biochemical testing.
  • No local or systemic infection.
  • Subjects and their families understand the clinical trial protocol and agree to participate in the trial, and sign a written Informed Consent.
  • Patients whose pain has lasted for more than half a year, and the routine clinical treatment of oral hormones, opioids and other drugs have been ineffective.

Exclusion criteria

Exclusion Criteria:

  • Those who are older than 70 years old or younger than 18 years old, or have no full capacity for civil conduct.
  • HIV, hepatitis virus or syphilis virus infection or positive serological test.
  • Body mass index (BMI) greater than 30 kg/m2.
  • Congenital or acquired knee deformity; severe knee arthritis accompanied by severe varus deformity, with varus greater than 10°.
  • Pregnant or lactating women, or women of childbearing age who have a positive pregnancy test within 7 days before receiving treatment.
  • Complicated with severe cardiovascular and cerebrovascular, liver, kidney, and endocrine, blood system diseases, malignant tumors, allergies, mental disorders, acute infections or local knee joint infections.
  • Patients with immunodeficiency.
  • Patients with a history of intra-articular injection within 3 months; patients being treated with immunosuppressive agents and glucocorticoids.
  • Patients who are still participating in other clinical trials.
  • Subjects who refuse to sign Informed Consent or refuse to participate in this clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Human umbilical cord mesenchymal stem cells

    Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients.

    Biological: Human umbilical cord mesenchymal stem cells

Interventions

  • BiologicalHuman umbilical cord mesenchymal stem cells

    Human umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients.

06

What researchers measure

Primary outcomes

  1. VAS score

    Changes of Visual Analogue Scale (VAS) score after injection

    Time frame: 1, 3, 6, 12 months after injection

Secondary outcomes

  1. Kellgren-Lawrence score

    Changes of Kellgren-Lawrence Score

    Time frame: 1, 3, 6, 12 months after injection

Other outcomes

  1. Lequesne Index

    Changes of the Lequesne Index

    Time frame: 1, 3, 6, 12 months after injection

  2. WOMAC score

    Changes of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

    Time frame: 1, 3, 6, 12 months after injection

  3. Symptom Grading Scale

    Changes of Symptom Grading Scale

    Time frame: 1, 3, 6, 12 months after injection

  4. SF-12

    Changes of the 12-Item Short Form Survey (SF-12)

    Time frame: 1, 3, 6, 12 months after injection

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05160831
Lead sponsor
Southwest Hospital, China
Responsible party
Liu Yang, MD (Professor of Center for Joint Surgery, Southwest Hospital, China) — Principal investigator
First posted
Dec 16, 2021
Start date
Jan 20, 2022 (estimated)
Primary completion
Jan 20, 2023 (estimated)
Completion
Jan 20, 2024 (estimated)
Last update
Dec 16, 2021

Study contacts

Fuyou Wang, MD
Contact
arthro@126.com
86-23-68765290
Liu Yang, MD
principal investigator · Center for Joint Surgery, Southwest Hospital, China
Fuyou Wang, MD
principal investigator · Center for Joint Surgery, Southwest Hospital, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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