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Knee OsteoarthritisPhase 1/2NCT01809769

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

A Phase 1/2 study testing Mesenchymal stem cells low-dose group, Mesenchymal stem cells mid-dose group and Mesenchymal stem cells high-dose group in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 1 site 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

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 more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Mesenchymal stem cells low-dose group, Mesenchymal stem cells mid-dose group and Mesenchymal stem cells high-dose group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Mar 2013to Jul 2015
Phase
Phase 1/2
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

    Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official title: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial

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).

Being tested
Mesenchymal stem cells low-dose group, Mesenchymal stem cells mid-dose group, Mesenchymal stem cells high-dose group
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 stem cells low-dose groupBiological

    Also called Adipose tissue derived mesenchymal stem cells

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

  • Mesenchymal stem cells mid-dose groupBiological

    Also called Adipose tissue derived mesenchymal stem cells

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

  • Mesenchymal stem cells high-dose groupBiological

    Also called Adipose tissue derived mesenchymal stem cells

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

Study groups in NCT01809769
Study groupRoleWhat they receive
Mesenchymal stem cells low-dose groupExperimentalBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.
Receives: Biological: Mesenchymal stem cells low-dose group
Mesenchymal stem cells mid-dose groupExperimentalBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Receives: Biological: Mesenchymal stem cells mid-dose group
Mesenchymal stem cells high-dose groupExperimentalBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Receives: Biological: Mesenchymal stem cells high-dose group

What is being measured

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

  1. Recording of Adverse Events and Serious Adverse Events

    Measured: 12 weeks

  2. Electrocardiogram

    Measured: 9 weeks

  3. Vital signs

    Measured: 9 weeks

  4. Physical examination

    Measured: 9 weeks

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

    Measured: 24 months

  6. Laboratory tests

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

    Measured: 9 weeks

Secondary outcomes (3)

  1. SF-36

    Measured: 24 months

  2. NRS-11

    Measured: 24 months

  3. The volume of articular cartilage

    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 posted13 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015
  4. Study completionJul 2015

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
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809769
Sponsor's protocol ID
CBMG-KOA-1.1
Status last verified
Apr 2016
First submitted
11 Mar 2013
Last updated
4 Apr 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mesenchymal stem cells low-dose group, Mesenchymal stem cells mid-dose group and Mesenchymal stem cells high-dose group in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 1 site 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 5 inclusion and 10 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

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?

Recording of Adverse Events and Serious Adverse Events (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 NCT01809769, 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 4 Apr 2016.

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