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Could umbilical cord stem cells ease knee arthritis pain?

NCT ID NCT03383081

Disease control Sponsor: Sclnow Biotechnology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether stem cells from umbilical cords can help people with knee osteoarthritis. Sixty participants will receive either a low or high dose of these cells injected into the knee joint. The goal is to see if the treatment is safe and can reduce pain and improve knee function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human umbilical cord mesenchymal stem cells
What this could lead to
If it works, this could provide a new treatment to control knee osteoarthritis, reducing pain and potentially delaying or avoiding joint replacement surgery.
What could go wrong
This is an early phase 2 trial with only 60 people, so results may not apply to everyone. Stem cell treatments can have side effects like infection or immune reactions, and the long-term benefits are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3 * Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance) * Age \<70, no serious organ dysfunction * Over 2 years knee pain or no very effective with conservative treatments * Knee pain of VAS (visual analog scale score) is 4 or higher * Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc. * Understand and sign the consent form of this study Exclusion Criteria: * Refuse to sign the consent form, or cannot keep follow-up visit * Age \>70; Age \<70, but with multiple organ failure * Unstable vital signs (breath, blood pressure, pulse) * Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc. * Serious bleeding tendency, poor coagulation function (PTA \<35%) * Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment * Participate other clinical experiments in 3 months * With progressing malignant tumor * Combined with shock and critically ill patients * With mental disease, cannot * With history of knee joint infection, surgery, and radiotherapy * With immunosuppressive agents treatment in 6 weeks * Injection with hormones and sodium hyaluronate in joint in 3 months * Overweight expressed as body mass index (BMI) \>35 * With skin disease around knee joint * With Immunodeficiency disease, including long term use immunosuppressive agents patients * Combined with serious infection * With some other conditions that doctor propose not to participate

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

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