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Could a single injection repair arthritic knees?

NCT ID NCT03291470

Disease control Sponsor: Kolon TissueGene, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This Phase 3 trial tested a single injection of TG-C, a cell-based treatment, in 531 people with moderate knee osteoarthritis. The goal was to see if it reduces pain and improves knee function compared to a placebo injection. Participants were followed for 24 months to check safety and effectiveness.

What this could mean

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

Active substance
TG-C (TissueGene-C), a single injection of cells that produce a growth factor to help repair knee cartilage
What this could lead to
If it works, this could provide a non-surgical treatment option that reduces pain and improves knee function for people with moderate knee osteoarthritis.
What could go wrong
This is a Phase 3 trial, but results are not yet published. The treatment may not work better than placebo, and there could be side effects from the injection or the cells.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

531 people

The number who actually took part.

Started

Dec 2021

Finished

May 2026

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

40 years and older

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: * Aged 40 or older * BMI between 18.5 and 40 * KL Grade 2 or 3 knee OA * OARSI Grade 1 or 2 medial JSN * Pain \>= 40 on VAS scale * Written informed consent * Using birth control Exclusion Criteria: * Knee symptoms that result in difficulty or inability to walk * Knee effusion \>2+ * Has Grade 3 OARSI JSN * Has a score of 0 or \>=5 on the cartilage feature of the WORMS at Screening * MRI exam indicates fracture or tumor * Has a positive result on RCR testing at screening * Has taken NSAIDS with 14 days of baseline * Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months of baseline * Chronic (\>21 days) narcotic use * Recent history (within 1 year) of drug or alcohol abuse * Pregnant or lactating * Has received injection to target knee within 2 months prior to study entry * History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis * Severe hip osteoarthritis ipsilateral to the target knee * Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV. * Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder. * Uncontrolled diabetes based on a HbA1c \> 8% at screening. * Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Degenerative osteoarthritis

Contacts and locations

Locations

  • Bassil Aish

    Huntington Beach, California, 92647, United States

  • David Scott

    Spokane, Washington, 99218, United States

  • Duane Anderson

    San Diego, California, 92120, United States

  • Durga Tanneru

    Dallas, Texas, 75230, United States

  • Edward Tavel

    Charleston, South Carolina, 29406, United States

  • Haresh Boghara

    Red Oak, Texas, 75154, United States

  • Igor Grosman

    Brooklyn, New York, 11235, United States

  • Jan Hommen

    Doral, Florida, 33126, United States

  • Jeremy Hoff

    Wilmington, North Carolina, 28412, United States

  • Jonathan Samuels

    New York, New York, 10016, United States

  • Larkin Wadsworth

    St Louis, Missouri, 63141, United States

  • Leonel Reyes

    San Antonio, Texas, 78215, United States

  • Lisa Blair

    San Antonio, Texas, 78229, United States

  • Manjoo Sharma

    Lewisville, Texas, 75057, United States

  • Miguel Trevino

    Clearwater, Florida, 33756, United States

  • Minal Desai

    Durham, North Carolina, 27704, United States

  • Mira Baron

    West Palm Beach, Florida, 33409, United States

  • Nathan Rimmke

    Rochester Hills, Michigan, 48307, United States

  • Nebojsa Skrepnik

    Tucson, Arizona, 85712, United States

  • Peter Hanson

    La Mesa, California, 91942, United States

  • Priyesh Mehta

    Dayton, Ohio, 45432, United States

  • Richard Radnovich

    Boise, Idaho, 83713, United States

  • Robby Ann Quintos

    Las Vegas, Nevada, 89109, United States

  • Samy Metyas

    Covina, California, 91722, United States

  • Steve Sitar

    Anaheim, California, 92801, United States

  • Stuart Silverman

    Beverly Hills, California, 90211, United States

  • Thomas Schnitzer

    Chicago, Illinois, 60611, United States

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