Knee OsteoarthrosisPhase 1NCT02966951
Use of Adipose Tissue Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
A Phase 1 study testing Adipose tissue derived mesenchymal stem cell in people with Knee Osteoarthrosis, run by Hanan Jafar at 1 site in Jordan.
Trial summary
Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis Read more about this study
- Who is it for?
- Ages 42 to 75 years
- Conditions the study is for
- Knee Osteoarthrosis
- What is being tested?
- Adipose tissue derived mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJordan
- Study dates
- 17 Jan 2017to Dec 2021
- 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 42 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
- Willing to participate by signing the informed consent
Who cannot join
- Sublaxation beyond 20 degrees of the bones of the knee joint
- Oral anticoagulants or heparin therapy
- Heart failure or arrhythmia
- Body Mass Index > 35
- Uncontrolled Diabetes Mellitus.
- Evidence of Infectious Diseases.
Show all 12Show fewer
- Active infection
- Malignancy
- Pregnancy
- Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
- Unreliable patients
- Non-resident in Jordan
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Cell Therapy Center
Amman, 11942
Abdalla Awidi, MD, 0096265355000, abdalla.awidi@gmail.com
About this study
Official title: Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Adipose Tissue Derived Mesenchymal Stem Cells (ATMSC) for Advanced Stage III and IV KOA
Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis
Read the detailed description
Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with Adipose Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
- Conditions
- Knee Osteoarthrosis
- Being tested
- Adipose tissue derived mesenchymal stem cell
- Keywords
- osteoarthrosis, knee, adipose tissue, stem cells, cell therapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue derived mesenchymal stem cellBiological
Intra-articular adipose tissue derived mesenchymal stem cell injection.
| Study group | Role | What they receive |
|---|---|---|
| adipose tissue mesenchymal stem cell | Experimental | Intra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose Receives: Biological: Adipose tissue derived mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of the intra articular injection
patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC
Measured: Time Frame: 6 months
Secondary outcomes (1)
Assessment of the efficacy of intra-articular injection of ATMSC
The efficacy of the intra-articular injection of ATMSC will be assessed by Magnetic Resonance Imaging (MRI).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start17 Jan 2017
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (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 Knee OsteoarthrosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanan Jafar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanan Jafar, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966951
- Sponsor's protocol ID
- ATKneeUJCTC
- Status last verified
- Apr 2021
- First submitted
- 15 Nov 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jafar H, Samara O, Shahin D, Daoud F, Al-Hattab D, Samara A, Al Lawama L, Hamdan M, Qubbaj H, Salah B, Awidi A. Intra-articular allogeneic adipose-derived mesenchymal stromal cell injections for stage III knee osteoarthritis: a double-blind placebo-controlled trial with 60-month follow-up. Stem Cells Transl Med. 2026 Apr 27;15(5):szag018. doi: 10.1093/stcltm/szag018.
PubMed 42049633
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Adipose Tissue Derived Mesenchymal Stem Cells (ATMSC) for Advanced Stage III and IV KOA
- ClinicalTrials.gov ID
- NCT02966951
- Acronym / sponsor ID
- ATKneeUJCTC
- Conditions
- Knee Osteoarthrosis
- Keywords
- osteoarthrosis, knee, adipose tissue, stem cells, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hanan JafarUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Nov 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.
Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis
Detailed description
Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with Adipose Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adipose tissue mesenchymal stem cell | Experimental | Biological: Adipose tissue derived mesenchymal stem cellIntra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose |
Who may qualify
- Ages
- 42 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
- Willing to participate by signing the informed consent
Key exclusion criteria (12 listed)
- Sublaxation beyond 20 degrees of the bones of the knee joint
- Oral anticoagulants or heparin therapy
- Heart failure or arrhythmia
- Body Mass Index > 35
- Uncontrolled Diabetes Mellitus.
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 |
|---|---|---|
| Adipose tissue derived mesenchymal stem cellIntra-articular adipose tissue derived mesenchymal stem cell injection. | Biological | adipose tissue mesenchymal stem cell |
Primary outcome
Evaluation of the safety and tolerability of the intra articular injection
Time frame: Time Frame: 6 months
patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC
1 secondary outcome
Assessment of the efficacy of intra-articular injection of ATMSC
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 42049633Jafar H, Samara O, Shahin D, Daoud F, Al-Hattab D, Samara A, Al Lawama L, Hamdan M, Qubbaj H, Salah B, Awidi A. Intra-articular allogeneic adipose-derived mesenchymal stromal cell injections for stage III knee osteoarthritis: a double-blind placebo-controlled trial with 60-month follow-up. Stem Cells Transl Med. 2026 Apr 27;15(5):szag018. doi: 10.1093/stcltm/szag018.
- Individual participant dataSharing planned: Undecided
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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.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adipose tissue derived mesenchymal stem cell in people with Knee Osteoarthrosis, run by Hanan Jafar at 1 site in Jordan.
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 2 inclusion and 12 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 28 Apr 2021. 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 Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Jafar, PhD (00962798871087, hanan.jafar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety and tolerability of the intra articular injection (time frame: Time Frame: 6 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 NCT02966951, 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 28 Apr 2021.