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Knee OsteoarthritisPhase 2NCT02162693

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

A Phase 2 study testing Mesenchymal progenitor cells and Sodium Hyaluronate in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 2 sites in China.

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

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Mesenchymal progenitor cells and Sodium Hyaluronate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesChina
Study dates
Nov 2013to Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is between 18-70 years of age, regardless of gender
  • The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
  • 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

Who cannot join

  • The subject has an allergic history or is of an allergic constitution
  • The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
  • The subject has severe infectious diseases or a malignant tumour
  • The subject has coagulation disorders
  • The subject has a BMI of over 30
Show all 14Show fewer
  • The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
  • The subject has received other intra-articular injections in the 2 months preceding the trial
  • 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
  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
  • The subject has a history of alcoholism, drug abuse, or mental illness
  • The subject has participated in any other clinical trial in the 3 months prior to this trial
  • The subject is pregnant, lactating or is planning to conceive within the next 6 months
  • The subject has any other unsuitable or adverse condition to be determined by the investigator

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • General Hospital of Chinese Armed Police Force

    Beijing

  • Shanghai Renji Hospital

    Shanghai, 200127

Other trials in China

About this study

Official title: A PhaseⅡb, Randomized, Double-blinded, Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

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.

Being tested
Mesenchymal progenitor cells, Sodium Hyaluronate
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • Mesenchymal progenitor cellsBiological

    Administrated for intra-articular injection

  • Sodium HyaluronateBiological

Study groups in NCT02162693
Study groupRoleWhat they receive
Mesenchymal progenitor cellsExperimentalAdministrated for intra-articular use of Mesenchymal progenitor cells
Receives: Biological: Mesenchymal progenitor cells
Sodium HyaluronateActive comparatorAdministrated for intra-articular use of Sodium Hyaluronate.
Receives: Biological: Sodium Hyaluronate

What is being measured

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

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

    Measured: 12 months

Secondary outcomes (1)

  1. Recording of Adverse Events and Serious Adverse Events

    Measured: 12 months

Timeline

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

  1. First posted13 Jun 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2016
  4. Study completionNov 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02162693
Sponsor's protocol ID
CBMG-KOA-Ⅱb
Status last verified
Nov 2017
First submitted
19 Mar 2014
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal progenitor cells and Sodium Hyaluronate in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 2 sites in China.

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 3 inclusion and 14 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 17 Nov 2017. 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 China. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) (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 NCT02162693, which also lists 1 linked publication.

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 17 Nov 2017.

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