Defect of Articular CartilagePhase 2NCT02855073
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
A Phase 2 study testing ReJoinTM and Sodium Hyaluronate in people with Defect of Articular Cartilage and Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Defect of Articular Cartilage, Knee Osteoarthritis
- What is being tested?
- ReJoinTM and Sodium Hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2019
- 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
- 18-70 years old, KOA couse ≤ 10 years
- Kellgren-Lawrence Ⅰ-Ⅲ
- VAS core >6， more than 4 months
- Signed informed consent from the subject
- cartilage defect 2-6cm2
Who cannot join
- Pregnancy test positive.
- Subject infected with hepatitis C, HIV or syphilis.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject deemed to be not suitable for the study by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects
The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.
Read the detailed description
This is a randomized, single-blind,phase II clinical trial.
At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.
In addition, external control will be added if necessary.
- Conditions
- Defect of Articular Cartilage, Knee Osteoarthritis
- Being tested
- ReJoinTM, Sodium Hyaluronate
- Keywords
- adipose-derived mesenchymal progenitor cells, Artz
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReJoinTMBiological
Also called adipose derived mesenchymal progenitor cells
adipose derived mesenchymal progeinitor cells
Sodium HyaluronateDrug
Also called Artz
Sodium Hyaluronate Injection
| Study group | Role | What they receive |
|---|---|---|
| ReJoinTM Group | Experimental | Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15. Receives: Biological: ReJoinTM |
| Sodium Hyaluronate Group | Active comparator | subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22. Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC scores
WOMAC scoring will be performed 48 weeks after the first injection
Measured: 48 weeks
Secondary outcomes (6)
VAS scores
VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Measured: 0 day、8 weeks、24 weeks、36 weeks and 48 weeks
SF-36 scores
SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Measured: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Outbridge scoring
Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
Measured: 1 day and 24 weeks
CRP
Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Measured: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Cartilage defect size
Cartilage defect size will be measured at 24 weeks after the first injection
Measured: 0 day and 24 weeks
Cartilage volume
Cartilage volume will be measured at 24 weeks after first injection
Measured: 0 day and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Defect of Articular CartilageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- You Wang, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855073
- Sponsor's protocol ID
- CBMG-ReJoinTM-CL-1.0
- Status last verified
- Dec 2018
- First submitted
- 8 Jul 2016
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Qiao Z, Tang J, Yue B, Wang J, Zhang J, Xuan L, Dai C, Li S, Li M, Xu C, Dai K, Wang Y. Human adipose-derived mesenchymal progenitor cells plus microfracture and hyaluronic acid for cartilage repair: a Phase IIa trial. Regen Med. 2020 Jan;15(1):1193-1214. doi: 10.2217/rme-2019-0068. Epub 2020 Feb 11.
PubMed 32043426
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects
- ClinicalTrials.gov ID
- NCT02855073
- Acronym / sponsor ID
- CBMG-ReJoinTM-CL-1.0
- Conditions
- Defect of Articular Cartilage, Knee Osteoarthritis
- Keywords
- adipose-derived mesenchymal progenitor cells, Artz
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- Jul 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.
Detailed description
This is a randomized, single-blind,phase II clinical trial.
At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.
In addition, external control will be added if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReJoinTM Group | Experimental | Biological: ReJoinTMSubjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15. |
| Sodium Hyaluronate Group | Active comparator | Drug: Sodium Hyaluronatesubjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-70 years old, KOA couse ≤ 10 years
- Kellgren-Lawrence Ⅰ-Ⅲ
- VAS core >6， more than 4 months
- Signed informed consent from the subject
- cartilage defect 2-6cm2
Key exclusion criteria (4 listed)
- Pregnancy test positive.
- Subject infected with hepatitis C, HIV or syphilis.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject deemed to be not suitable for the study by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReJoinTMAlso: adipose derived mesenchymal progenitor cellsadipose derived mesenchymal progeinitor cells | Biological | ReJoinTM Group |
| Sodium HyaluronateAlso: ArtzSodium Hyaluronate Injection | Drug | Sodium Hyaluronate Group |
Primary outcome
WOMAC scores
Time frame: 48 weeks
WOMAC scoring will be performed 48 weeks after the first injection
6 secondary outcomes
VAS scores
Time frame: 0 day、8 weeks、24 weeks、36 weeks and 48 weeks
SF-36 scores
Time frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Outbridge scoring
Time frame: 1 day and 24 weeks
CRP
Time frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Cartilage defect size
Time frame: 0 day and 24 weeks
Cartilage volume
Time frame: 0 day and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Derived from this study: PubMed 32043426Qiao Z, Tang J, Yue B, Wang J, Zhang J, Xuan L, Dai C, Li S, Li M, Xu C, Dai K, Wang Y. Human adipose-derived mesenchymal progenitor cells plus microfracture and hyaluronic acid for cartilage repair: a Phase IIa trial. Regen Med. 2020 Jan;15(1):1193-1214. doi: 10.2217/rme-2019-0068. Epub 2020 Feb 11.
- Individual participant dataSharing planned: Undecided
Related trials for Defect of Articular Cartilage
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
You Wang study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ReJoinTM and Sodium Hyaluronate in people with Defect of Articular Cartilage and 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 4 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: status not confirmed, as of the sponsor's last update on 17 Dec 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 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?
Results are not available in the source record.
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 scores (time frame: 48 weeks). 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 NCT02855073, 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 Dec 2018.