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Degeneration Articular Cartilage KneePhase 1/2NCT01733186

Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects

A Phase 1/2 study testing CARTISTEM® in people with Degeneration Articular Cartilage Knee, run by Medipost, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degeneration Articular Cartilage Knee
What is being tested?
CARTISTEM®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
7 Jan 2013to 29 Aug 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with an intended- to- treat single focal, full-thickness cartilage defect (ICRS [International Cartilage Repair Society] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases.
  • Age ≥ 18 years old
  • Size of the articular cartilage lesion is ≥ 2 cm2
  • Swelling, tenderness and active range of motion ≤ Grade II
  • Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
  • Appropriate blood coagulation, kidney and liver function laboratory parameters: PT(INR) < 1.5, APTT <1.5×control Creatinine ≤ 2.0 mg/dL Albumin ≤ trace in urine dipstick test Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L
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  • Ligament instability ≤ Grade II
  • Lower extremity alignment within 5 degrees of the neutral weight bearing axis
  • No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
  • Ability and willingness to fully participate in the post-operative rehabilitation program
  • Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures
  • Body Mass Index (BMI) ≤ 35 kg/m2

Who cannot join

  • Patients who have been treated previously and are asymptomatic
  • Avascular necrosis/ osteonecrosis
  • Autoimmune or inflammatory joint disease
  • History of infection within the past 6 weeks
  • Surgery or radiation therapy within the past 6 weeks
  • Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator
Show all 17Show fewer
  • Currently pregnant or nursing
  • Psychotic diseases, epilepsy, or any history of such diseases
  • Current abuse of alcohol (> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker
  • Chronic inflammatory articular diseases such as rheumatoid arthritis
  • Enrolled in any other clinical trials within the past 4 weeks
  • Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks
  • Ligament instability > Grade II
  • Uncorrected significant lower extremity malalignment (i.e. > 5 degrees)
  • (sub-) Total meniscectomy (<5mm rim remaining)
  • Corticosteroid or viscosupplementation injection to the affected knee in the past 3 months
  • Principal investigator considers inappropriate for the clinical trial due to any reasons other than those listed above

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cartilage Repair Center; Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467

  • Cartilage Restoration Center; RUSH University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects: A Phase I/IIa Clinical Trial in Patients With Focal, Full-thickness Grade 3-4 Articular Cartilage Defects of the Knee

The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Read the detailed description

Conventional treatment modalities have not been able to provide complete and sustained resolution of symptoms following damage to the articular cartilage. Despite the numerous techniques available today, complete healing of damaged or defective cartilage or consistent reproduction of normal hyaline cartilage does not occur, and continuous drug administration or secondary surgeries are common.

Research in mesenchymal stem cells has had a rapid acceleration over the past decade and MSC-based therapy has become one of the objects of investigation for a new branch of medicine termed regenerative medicine. This emerging technology shows great promise for producing transplantable cartilage constructs to restore the function of degenerated joints.

CARTISTEM®, a combination of human umbilical cord blood-derived mesenchymal stem cells and sodium hyaluronate, is intended to be used as a single-dose cellular therapeutic agent for cartilage regeneration in human subjects with cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Being tested
CARTISTEM®
Keywords
human umbilical cord blood-derived mesenchymal stem cells, MSC, cartilage lesion, cartilage defect, degenerative arthritis, stem cell implantation
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CARTISTEM®Biological

    Also called human umbilical cord blood-derived mesenchymal stem cells

Study groups in NCT01733186
Study groupRoleWhat they receive
CARTISTEM®ExperimentalDrug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect
Receives: Biological: CARTISTEM®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IKDC Score

    Subjects underwent a self-assessment of knee function using the IKDC (International Knee Documentation Committee Assessment)subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.

    The IKDC assessment was performed before IP administration and at Months 12 after IP administration in an exploratory fashion. The IKDC score from the Month 12 visit was used as a primary indicator of the post operative change.

    The outcome was presented with the post-operative change amount from the baseline.

    Measured: 12 months

Secondary outcomes (4)

  1. VAS

    Subjects underwent a self-assessment of joint pain using the 100-mm VAS (Visual Analogue Scale) before and at Months 12 and 24 after IP (investigational product) administration. Higher values represent worse joint pain. Use of NSAIDs and any other analgesics had to be discontinued for 48 hours and 24 hours, respectively, prior to the 100 mm VAS evaluation. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline.

    100-mm VAS scores range from 0 to 100. Higher values represent worse joint pain.

    Measured: 24 months

  2. Lysholm Score

    The Lysholm knee scoring scale is a self-assessment that rates the severity of common complaints related to knee problems, such as pain, swelling, abnormal sensations, and ability to squat or climb stairs. The possible score ranges from 0 to 100, where 100 = no symptoms or disability. Scores are categorized as excellent (95 to 100), good (84 to 94), fair (65 to 83), and poor (≤64). Subjects underwent a self-assessment of knee function using the Lysholm score before IP administration and at Months 12 and 24 after IP administration. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline.

    Measured: 24 months

  3. KOOS Score

    The Knee Injury and Osteoarthritis Outcome score (KOOS) knee survey is a self assessment of knee function and knee-related quality of life (QOL). Subjects responded to each question regarding knee-related symptoms, swelling, pain, impaired function, or changes in QOL with 1 of 5 possible answers that range from "never/not at all" to "always/extremely." The possible score for each parameter ranges from 0 to 100, where 0=extreme problems and 100=no problems. Subjects completed the KOOS knee survey before IP (investigational product) administration and at Month 24 after IP administration. The outcome was presented with the post-operative change amount at Month 24 from the baseline.

    Measured: 24 months

  4. IKDC Score

    Subjects underwent a self-assessment of knee function using the IKDC subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Month 24 after IP administration in an exploratory fashion. The outcome was presented with the post-operative change amount at Month 24 from the baseline.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2012 (estimated)
  2. Study start7 Jan 2013
  3. Primary completion2 Jun 2017
  4. Study completion29 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01733186
Sponsor's protocol ID
MP-0201-01
Status last verified
Jan 2026
First submitted
20 Nov 2012
Last updated
29 Jan 2026
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CARTISTEM® in people with Degeneration Articular Cartilage Knee, run by Medipost, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IKDC Score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01733186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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