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Could a single injection rebuild knees? phase 3 trial underway

NCT ID NCT03203330

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a single injection of TG-C, a cell-based treatment, in 535 people with moderate knee osteoarthritis. The goal is to see if it reduces pain and improves knee function compared to a placebo injection. Participants are followed for two years 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 release a growth factor to help repair knee cartilage
What this could lead to
If it works, this could provide a new, non-surgical treatment option for knee osteoarthritis that reduces pain and improves knee function.
What could go wrong
This is an early Phase 3 trial, so results are not yet confirmed. 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

535 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Aug 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

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 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

  • Adil Fatakia

    Marrero, Louisiana, 70072, United States

  • Alan Kivitz

    Duncansville, Pennsylvania, 16635, United States

  • Aldo Maspons

    El Paso, Texas, 79225, United States

  • Amr Morsy

    Dallas, Texas, 75240, United States

  • Anand Patel

    Winter Park, Florida, 32789, United States

  • Arthur Mabaquiao

    San Diego, California, 92108, United States

  • Aurelio Torres-Consuegra

    Miami, Florida, 33144, United States

  • Bradly Goodman

    Birmingham, Alabama, 35235, United States

  • Brett Gilbert

    Durham, North Carolina, 27704, United States

  • Brian MacGillivray

    San Antonio, Texas, 78258, United States

  • Cathy Barnes

    New Port Richey, Florida, 34652, United States

  • Dan La

    Covina, California, 91722, United States

  • Daneshvari Solanki

    Bellaire, Texas, 77401, United States

  • David Billmeier

    Daytona Beach, Florida, 32117, United States

  • Dennis Levinson

    Chicago, Illinois, 60607, United States

  • Diraj Karnani

    Apple Valley, California, 92307, United States

  • Edgar Gonzalez

    Miami, Florida, 33144, United States

  • Edward Tavel

    Columbia, South Carolina, 29206, United States

  • Eric Grigsby

    Napa, California, 94558, United States

  • Eric Loudermilk

    Greenville, South Carolina, 29601, United States

  • Haresh Boghara

    DeSoto, Texas, 75115, United States

  • Harvey Bowles

    Nashville, Tennessee, 37203, United States

  • Howard Chipman

    Oldsmar, Florida, 34677, United States

  • Hythem Shadid

    Oak Brook, Illinois, 60523, United States

  • James Nace

    Baltimore, Maryland, 21215, United States

  • Jason Oh

    New York, New York, 10075, United States

  • Jeffrey Davis

    Birmingham, Alabama, 35205, United States

  • Jeremy Hoff

    Wilmington, North Carolina, 28412, United States

  • John Hemmersmeier

    South Ogden, Utah, 84405, United States

  • Kristen Holtz

    Charlottesville, Virginia, 22901, United States

  • Manish Jain

    Chicago, Illinois, 60640, United States

  • Mark Hermann

    Danville, Virginia, 24541, United States

  • Mehul Desai

    Washington D.C., District of Columbia, 20006, United States

  • Melvin Churchill

    Lincoln, Nebraska, 68516, United States

  • Mercedes Ponce De Leon

    Miami, Florida, 33135, United States

  • Nebojsa Skrepnik

    Tucson, Arizona, 85712, United States

  • Richard Linn

    Sunrise, Florida, 33351, United States

  • Saima Chohan

    Phoenix, Arizona, 85032, United States

  • Sandeep Vaid

    Newnan, Georgia, 30265, United States

  • Scott Hacker

    La Mesa, California, 91942, United States

  • Subodh Bhuchar

    Houston, Texas, 77099, United States

  • Tien-I Su

    Whittier, California, 90602, United States

  • Timothy Davis

    Santa Monica, California, 90403, United States

  • Yogesh Mittal

    Tulsa, Oklahoma, 74104, United States

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