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CompletedNCT02162693Updated Nov 17, 2017

Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis

A Phase 2 interventional study of Mesenchymal progenitor cells and Sodium Hyaluronate in Knee Osteoarthritis, sponsored by Shanghai AbelZeta Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

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

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Current medication treatments for KOA aim to relieve inflammation and pain, but they do little to delay or reverse the disease progression and most medications have obvious side effects. When the conservative treatments are useless to patients and joint deformities and joint disfunction, the patients may require surgery. Although surgery of the joints can relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.

Read the detailed description

Human adipose-derived mesenchymal progenitor cells (haMPCs) are obtained through a series of procedures: firstly, the fresh adipose tissue is digested with collagenase, filtered, centrifuged and then discard mature adipose cells to obtain adipose tissue-derived nuclear cells also called stromal vascular fraction cells (SVFs). In the end, haMPCs are prepared after being purified andamplified to P2-P5. When induced by specific factors, haMPCs have a potential for multilineage differentiation towards bone, cartilage and fat tissue both in vivo and in vitro. The haMPCs can secrete a number of soluble mediators to stimulate the proliferation of endogenous progenitor cells, to act as nutrients, to be immunosuppressive, to be anti-inflammatory, to prevent fibrosis and promote angiogenesis. The cytokines secreted by haMPCs play a synergic role in restoring the dynamic balance of synthesis and decompositon of cartilage tissue, and finally to repair the impaired cartilage.

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 enrollment of 53 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.

04

Who can participate

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

Inclusion criteria

  1. The subject is between 18-70 years of age, regardless of gender
  2. The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
  3. The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms

Exclusion criteria

Exclusion Criteria:

  1. The subject has an allergic history or is of an allergic constitution
  2. The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
  3. The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
  4. The subject has severe infectious diseases or a malignant tumour
  5. The subject has coagulation disorders
  6. The subject has a BMI of over 30
  7. The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
  8. The subject has received other intra-articular injections in the 2 months preceding the trial
  9. The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular， Hemochromatosis，inflammatory arthropathy，avascular necrosis of femoral head，Paget's disease，hemophilic arthropathy，infectional arthritis，Charcot's disease，villonodular synovitis or synovial chondromatosis
  10. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
  11. The subject has a history of alcoholism, drug abuse, or mental illness
  12. The subject has participated in any other clinical trial in the 3 months prior to this trial
  13. The subject is pregnant, lactating or is planning to conceive within the next 6 months
  14. The subject has any other unsuitable or adverse condition to be determined by the investigator
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Mesenchymal progenitor cells

    Administrated for intra-articular use of Mesenchymal progenitor cells

    Biological: Mesenchymal progenitor cells

  • Active comparator
    Sodium Hyaluronate

    Administrated for intra-articular use of Sodium Hyaluronate.

    Biological: Sodium Hyaluronate

Interventions

  • BiologicalMesenchymal progenitor cells

    Administrated for intra-articular injection

  • BiologicalSodium Hyaluronate
06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Recording of Adverse Events and Serious Adverse Events

    Time frame: 12 months

07

Study locations

2 sites
  • General Hospital of Chinese Armed Police Force
    Beijing, China
  • Shanghai Renji Hospital
    Shanghai, 200127, China
08

References and documents

Publications

  • Lu L, Dai C, Zhang Z, Du H, Li S, Ye P, Fu Q, Zhang L, Wu X, Dong Y, Song Y, Zhao D, Pang Y, Bao C. Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial. Stem Cell Res Ther. 2019 May 21;10(1):143. doi: 10.1186/s13287-019-1248-3. PubMed 31113476 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02162693
Lead sponsor
Shanghai AbelZeta Ltd.
Collaborators
RenJi Hospital, General Hospital of Chinese Armed Police Force
Responsible party
Sponsor
First posted
Jun 13, 2014
Start date
Nov 2013
Primary completion
May 2016
Completion
Nov 2016
Last update
Nov 17, 2017

Study contacts

Chunde Bao, MD
principal investigator · RenJi Hospital
Zhongwen Zhang, MD
principal investigator · General Hospital of Chinese Armed Police Force

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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