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OsteoarthritisPhase 1NCT02641860

Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

A Phase 1 study testing Mesenchymal progenitor cells in people with 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

Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Osteoarthritis
What is being tested?
Mesenchymal progenitor cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
Dec 2015to Mar 2018
Phase
Phase 1
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

  • Object has an allergic history or is of an allergic constitution.
  • Subjects who understand and sign the consent form for this study.
  • Age: 18-70, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)> 4 months.
  • Course of Knee osteoarthritis:6 months to 10 years;
  • The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).

Who cannot join

  • The subject has an allergic history of medicine or food。.
  • The subject'BMI is over 30.
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung， endocrine system.
  • The subject has an history malignant tumour.
  • The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articularis， 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 has severe generalized infectious diseases or local knee infection in the 3 months prior to this trial.
Show all 19Show fewer
  • The subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
  • The subject has coagulation disorders.
  • The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.
  • The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.
  • The subject has received aminoglucose or chondroitin sulfate in the 6 months preceding the trial.
  • The subject has plan of knee prosthesis within the trial.
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker、defibrillator、heart bracket、heart valve prosthesis、metal clip after aneurysm surgery、drug infusion device implanted in vivo、any electronic device implanted in the body（nerve stimulator、bone growth stimulator）、endovascular coil、strainer、ECG monitor、metal suture、shrapnel or sand of body, plate fixation and steel nail after fracture
  • Page 4 of 4 [DRAFT] - surgery、artificial limb or joint、audiphone、artificial cochlea、middle ear shift plant、metallic intraocular foreign body etc； claustrophobia、pregnancy within 3 months、critically ill patients.
  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject is pregnant, lactating or 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

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: A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

Read the detailed description

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.

Conditions
Osteoarthritis
Being tested
Mesenchymal progenitor cells
Medical subject headings
Osteoarthritis

What participants receive

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

  • Mesenchymal progenitor cellsBiological

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

Study groups in NCT02641860
Study groupRoleWhat they receive
Mesenchymal progenitor cells Dosage 1OtherMesenchymal progenitor cells low-dose group
Receives: Biological: Mesenchymal progenitor cells
Mesenchymal progenitor cells Dosage 2OtherMesenchymal progenitor cells mid-dose group
Receives: Biological: Mesenchymal progenitor cells
Mesenchymal progenitor cells Dosage 3OtherMesenchymal progenitor cells high-dose group
Receives: Biological: Mesenchymal progenitor cells

What is being measured

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

  1. Safety, recording of Adverse Events and Serious Adverse Events

    Measured: 12 weeks,48 weeks

  2. WOMAC Score

    Measured: 48 weeks

Secondary outcomes (4)

  1. VAS Score

    Measured: 48 weeks

  2. SF-36

    Measured: 48 Weeks

  3. The volume of articular cartilage

    Measured: 48 weeks

  4. WORMS Score

    Measured: 48 weeks

Timeline

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

  1. First posted30 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2018
  4. Study completionMar 2018

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641860
Sponsor's protocol ID
CBMG-Allo-KOA-1.1
Status last verified
Sep 2018
First submitted
21 Dec 2015
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, Li S, Xu C, Lu Q, Dai C. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Res Ther. 2019 Oct 21;10(1):308. doi: 10.1186/s13287-019-1406-7.

    PubMed 31639063

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mesenchymal progenitor cells in people with 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 6 inclusion and 19 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 13 Sep 2018. 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 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.

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?

Safety, recording of Adverse Events and Serious Adverse Events (time frame: 12 weeks,48 weeks). The study lists 2 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 NCT02641860, 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 13 Sep 2018.

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