CClinicalTrials.gg
Status unknownNCT04130100Updated Oct 17, 2019

Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis

An Early Phase 1 interventional study of Low Dose of Mesenchymal stem cell and High Dose of Mesenchymal stem cell in Knee Osteoarthritis, sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-17.

Sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2019, registered Oct 2019).
Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate.

20 participants will receive low dose of dental pulp mesenchymal stem cells, 20 participants will receive high dose and another 20 participants will receive sodium hyaluronate

Read the detailed description

60 participants will receive to evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate and verify the basis of dental pulp mesenchymal stem cells in the treatment of primary knee osteoarthritis, and to explore a more effective and safe clinical treatment of knee osteoarthritis.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

CAR-T (Shanghai) Biotechnology Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Complying with the diagnostic criteria for primary knee osteoarthritis revised by the American Rheumatological Association (1995), age 40-70 years, gender-free.
  2. For patients with mild to moderate knee arthritis, the WOMAC score of knee joint was less than 120.
  3. X-ray Kellgren-Lawrence was used to evaluate the grade I, II and III of osteoarthritis.
  4. Fertility patients should take effective contraceptive measures until the end of follow-up. Fertility women should exclude the possibility of early pregnancy, that is, HCG negative test in early pregnancy.
  5. Voluntary participation in this clinical study, can cooperate with doctors to carry out research, stop all medical measures for knee arthritis for more than 2 weeks, and sign the informed consent of patients.

Exclusion criteria

Exclusion Criteria:

(1) Those with other diseases that may affect the knee joint, such as rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, gout and other rheumatic diseases, bone tumors, osteoporosis, bone tuberculosis or obvious history of acute trauma, resulting in meniscus injury, ligament rupture and vascular nerve injury; those with previous history of femur, tibial plateau, tibia and fibula fracture. The patients with gonarthritis, the patients with knee joint and surrounding skin infection were not cured.

  1. Patients who have undergone surgery and other factors affecting the efficacy of the treatment. Patients with severe deformities or even deformities of the knee joint, who need surgical treatment. Patients who have received knee joint irrigation or arthroscopic examination within one year.
  1. Patients with systemic cancer tendency or cancer and patients with systemic infection in active stage.
  1. Patients with severe heart, lung, liver, kidney, blood system, endocrine system and immune deficiency, or abnormal laboratory biochemical indicators, namely: hemoglobin (Hb) \< 9 g/dL, white blood cell (WBC) > 15 x 109/L, platelet (Pt) \< 100 x 109/L, glutamic oxalate transaminase (AST) and alanine aminotransferase (ALT) > 1.5 times normal upper limit; serum creatinine > 1.5 times normal upper limit.
  1. Physical history or clinical manifestations with bleeding tendency, including patients currently using anticoagulants.
  1. Patients with uncontrollable epileptic seizures, psychosis or Alzheimer's disease who are unable to complete the scale.
  1. Pregnant or lactating women, legal disabled patients (blind, deaf, dumb, mentally retarded, physically disabled), drug addiction and other adverse drug addiction.
  1. Patients with contraindications or allergies were examined and treated in this study.
  1. Those who have participated in other clinical studies within one month.
  1. Researchers consider it inappropriate for patients to participate in this clinical study.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Low Dose of Mesenchymal stem cell

    Patients receiving intraarticular injection of low dose of mesenchymal stem cells.

    Biological: Low Dose of Mesenchymal stem cell

  • Experimental
    High Dose of Mesenchymal stem cell

    Patients receiving intraarticular injection of high dose of mesenchymal stem cells.

    Biological: High Dose of Mesenchymal stem cell

  • Active comparator
    Sodium Hyaluronate

    Patients receiving intraarticular injection of Sodium Hyaluronate

    Drug: Sodium Hyaluronate

Interventions

  • BiologicalLow Dose of Mesenchymal stem cell

    Mesenchymal stem cell injection

    Also known as: 1

  • BiologicalHigh Dose of Mesenchymal stem cell

    Mesenchymal stem cell injection

    Also known as: 2

  • DrugSodium Hyaluronate

    Sodium Hyaluronate injection

    Also known as: 3

06

What researchers measure

Primary outcomes

  1. Kellgren and Lawrence's rating

    X-ray imaging was used to evaluate the degree of improvement in knee joint structure

    Time frame: 12 month

  2. WOMAC score

    WOMAC score decreased

    Time frame: 12 month

Secondary outcomes

  1. Volume of femoral surface of knee joint on MRI

    Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI

    Time frame: 12 month

  2. relaxation time of femoral surface of knee joint on MRI

    Changes of relaxation time (T1 condylar, T2 condylar, T2\*) of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI

    Time frame: 12 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04130100
Lead sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Oct 17, 2019
Start date
Apr 4, 2019
Primary completion
Sep 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Oct 17, 2019

Study contacts

Dongbao Zhao, Doctor
Contact
aolin_521@163.com
+86-18317079530
Dongbao Zhao, Doctor
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion