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CompletedNCT01809769Updated Apr 4, 2016

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

A Phase 1/2 interventional study of Mesenchymal stem cells low-dose group and Mesenchymal stem cells mid-dose group in Knee Osteoarthritis, sponsored by Shanghai AbelZeta Ltd.. Completed at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-04.

Sponsored by Shanghai AbelZeta Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Read the detailed description

Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Shanghai AbelZeta Ltd. is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • Subjects who understand and sign the consent form for this study.
  • Age: 40-70, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
  • Patients who can't treat with traditional medication and need a arthroplasty.
  • Duration of pain over Grade 4(11-point numeric scale)> 4 months.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or breast feeding or planning to become pregnant during the study.
  • Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.
  • History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
  • Treatment with intra-articular injection therapy within 2 months prior to screen.
  • Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
  • Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).
  • Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Mesenchymal stem cells low-dose group

    Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.

    Biological: Mesenchymal stem cells low-dose group

  • Experimental
    Mesenchymal stem cells mid-dose group

    Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

    Biological: Mesenchymal stem cells mid-dose group

  • Experimental
    Mesenchymal stem cells high-dose group

    Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

    Biological: Mesenchymal stem cells high-dose group

Interventions

  • BiologicalMesenchymal stem cells low-dose group

    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

    Also known as: Adipose tissue derived mesenchymal stem cells

  • BiologicalMesenchymal stem cells mid-dose group

    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

    Also known as: Adipose tissue derived mesenchymal stem cells

  • BiologicalMesenchymal stem cells high-dose group

    Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

    Also known as: Adipose tissue derived mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. Recording of Adverse Events and Serious Adverse Events

    Time frame: 12 weeks

  2. Electrocardiogram

    Time frame: 9 weeks

  3. Vital signs

    Time frame: 9 weeks

  4. Physical examination

    Time frame: 9 weeks

  5. WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: 24 months

  6. Laboratory tests

    Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests

    Time frame: 9 weeks

Secondary outcomes

  1. SF-36

    Time frame: 24 months

  2. NRS-11

    Time frame: 24 months

  3. The volume of articular cartilage

    Time frame: 24 months

07

Study locations

1 site
  • Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
    Shanghai, Shanghai 200127, China
08

References and documents

Publications

  • Song Y, Du H, Dai C, Zhang L, Li S, Hunter DJ, Lu L, Bao C. Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections. Regen Med. 2018 Apr;13(3):295-307. doi: 10.2217/rme-2017-0152. Epub 2018 Feb 8. PubMed 29417902 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01809769
Lead sponsor
Shanghai AbelZeta Ltd.
Collaborators
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 13, 2013
Start date
Mar 2013
Primary completion
Mar 2015
Completion
Jul 2015
Last update
Apr 4, 2016

Study contacts

Chunde Bao, M.D. & Ph.D.
principal investigator · Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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