Actively Recruiting

Phase 2
Age: 0 - 70Years
All Genders
NCT03383081

The Safety/Efficacy of hUC Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis

Led by Sclnow Biotechnology Co., Ltd. · Updated on 2025-12-04

60

Participants Needed

1

Research Sites

430 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease

CONDITIONS

Official Title

The Safety/Efficacy of hUC Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis

Who Can Participate

Age: 0 - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of knee osteoarthritis with Kellgren and Lawrence Grade 2-3
  • Confirmed cartilage injury by MRI, including partial or full-thickness damage
  • Age under 70 years with no serious organ dysfunction
  • Knee pain lasting more than 2 years or poor response to conservative treatment
  • Knee pain score of 4 or higher on the Visual Analog Scale
  • Normal liver and kidney function
  • No history of gout, rheumatoid arthritis, or autoimmune diseases
  • Able to understand and sign the study consent form
Not Eligible

You will not qualify if you...

  • Refusal or inability to sign the consent form or to attend follow-up visits
  • Age over 70 or under 70 with multiple organ failure
  • Unstable vital signs such as breathing, blood pressure, or pulse
  • Knee ligament rupture or laxity
  • Serious bleeding or poor blood clotting (PTA less than 35%)
  • Pregnant, breastfeeding, or positive pregnancy test within 7 days before treatment
  • Participation in other clinical trials within the last 3 months
  • Progressive malignant tumors
  • Shock or critical illness
  • Mental illness preventing participation
  • History of knee joint infection, surgery, or radiotherapy
  • Use of immunosuppressive drugs in the last 6 weeks
  • Injection of hormones or sodium hyaluronate into the joint in the last 3 months
  • Body mass index over 35
  • Skin disease around the knee joint
  • Immunodeficiency or long-term immunosuppressive treatment
  • Serious infections
  • Other conditions deemed unsuitable by the doctor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

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Research Team

L

Lei Guo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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