Osteo Arthritis KneePhase 1/2NCT06084988
A Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis
A Phase 1/2 study testing Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte) in people with Osteo Arthritis Knee, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
Trial summary
This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 7 Nov 2023to 29 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and comply with all procedures required by the protocol
- Aged > 18 years at the time of signing the informed consent form
- Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis.
- Kellgren-Lawrence radiological classification scale II and III at screening
- Visual analogue scale (VAS) joint pain ≥ 2.5 at screening
- Have tried but failed conservative management including physical therapy, bracing and medications for a minimum of three months.
Show all 13Show fewer
- No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
- No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
- Adequate liver and renal functions with non-malignant blood profile.
- Body Mass Index between 20 and 30 kg/m2
- Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
- Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
- Fluid > 1 cm within the lateral recess of the suprapatellar pouch at the level of the superior pole of the patella with the knee extended.
Who cannot join
- Unwilling or unable to perform any of the assessments required by the protocol
- Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
- Patients with varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs
- Patients with a history of a previous subtotal medial or lateral meniscectomy
- Patients with a history of septic arthritis in the affected joint
- Patients with a history of a prior intra-articular knee fracture
Show all 12Show fewer
- Severe bleeding diathesis
- Active infection
- Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g., patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator
- Patients with neoplasia
- Patients participating in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in this study
- Patients with a known history of inflammatory or rheumatic diseases such as rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis
This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. The main questions it aims to answer are:
To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs).
Eligible patients will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasoundguided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte
Read the detailed description
Osteoarthritis (OA) is a severe, chronic, and progressive disease that eventually leads to disability. OA is characterized by joint pain, stiffness, limited mobility with effusion, and inflammation. It has a negative physical and psychological impact which results in a reduced quality of life. OA occurs as an imbalance between the formation and degeneration of chondrocytes and extracellular matrix which leads to progressive destruction of articular cartilage. OA symptoms were routinely managed using pharmacologic treatments including hyaluronic acid (HA) and platelet rich plasma (PRP) injections. Recent guidelines have recommended against the use of these agents. Both treatments are mainly given for pain relief and have minimal effects on stopping the progression of OA; hyaluronic acid (HA) leads to a small reduction in knee osteoarthritis pain compared with placebo, while PRP, did not result in a significant difference in symptoms or joint structure. These findings do not support broad use of them for the treatment of knee osteoarthritis.
Mesenchymal Stromal Cells (MSCs) are one of the emerging, regenerative therapies that aim to treat, prevent and even reverse OA through their immunomodulatory properties that reduce inflammation and promote angiogenesis. MSCs are proven to regulate the body's immune response in many diseases and exert anti-inflammatory effects. These immunomodulatory properties are mediated via paracrine mechanisms. Following their discovery over 50 years ago, mesenchymal stromal cells (MSCs) have become one of the most studied cellular therapeutic products by both academia and industry due to their regenerative potential and immunomodulatory properties. The promise of MSCs as a therapeutic modality has been demonstrated in a number of preclinical data as well as in clinical setting. Stromaforte cells which will be used in this study is developed within CELLCOLABS AB and were generated following the same protocol established over the last 20 years by scientists CELLCOLABS AB at the Karolinska Institute in Sweden. MSCs showed a very promising effect in patients including vocal folds, GVHD, ARDS, multiple sclerosis and recently in patients severely infected with COVID virus.
The currently completed preclinical studies on animal models showed that intra-articular injection of MSCs can promote cartilage regeneration and reduce joint inflammation to improve the OA function of joints, and no malignant transformation of MSCs has been found as well as randomized double blinded phase I/II clinical studies reported that, the clinical manifestations, radiological and histological scores of OA patients were improved, no graft-related death, tumorigenesis and infection occurred, and no serious adverse reactions were observed. These studies demonstrated safety and tolerability of the MSCs. Based on the above results preclinical and clinical studies, it is planned to conduct this study which has been designed to evaluate the safety and tolerability of intra-articular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte in mild-to-moderate stage knee osteoarthritis patients before further clinical development.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)Biological
50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given via ultrasound-guided intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| MSC Intervention Group | Experimental | Participants will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasound-guided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. All patients will be observed for at least 2 hours post-injection at the study site. Both active monitoring and spontaneous reporting will be used. Receives: Biological: Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability within 24 hours,4 days , 28, 84 and 168 days of MSC injection
To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment
Measured: From baseline to 6 months
Secondary outcomes (10)
Change from baseline in subjective pain assessment according to the VAS questionnaire 84, 168 days after treatment
Change from baseline in subjective pain assessment according to the VAS questionnaire 84, 168 days after treatment. The highest pain being a number 10 on the scale and 0 the lowest.
Measured: From baseline to 6 months
Change from baseline in knee-joint specific function assessed by the Knee Injury and osteoarthritis outcome score (KOOS) at 84- and 168-days post-injection
Change from baseline in knee-joint specific function assessed by the Knee Injury and osteoarthritis outcome score (KOOS) at 84- and 168-days post-injection. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL) totalling 42 items. Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: From baseline to 6 months
Change from baseline in arthritis pain scores using the Lequesne index assessment at 84- and 168-days post treatment
Change from baseline in arthritis pain scores using the Lequesne index assessment at 84- and 168-days post treatment.
Measured: From baseline to 6 months
Change in Health-related quality of life according to Short-Form 12 at 168 days post-injection
Change in Health-related quality of life according to Short-Form 12 at 168 days post-injection. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: From baseline to 6 months
Change in TNF-alpha in synovial fluid
Change in TNF-alpha in synovial fluid from baseline to 168 days post-injection
Measured: From baseline to 6 months
Change in C Reactive Protein (CRP) in synovial fluid
Change in C Reactive Protein (CRP) in synovial fluid from baseline to 168 days post-injection
Measured: From baseline to 6 months
Change in Interleukin-6 (IL-6) in synovial fluid
Change in Interleukin-6 (IL-6) in synovial fluid from baseline to 168 days post-injection
Measured: From baseline to 6 months
Change from baseline at levels of catabolic/anabolic products of collagens
Change from baseline at levels of catabolic/anabolic products of collagens in urine and/or serum at 84- and 168-days post-injection
Measured: From baseline to 6 months
Change from baseline level in joint space changes within the knee
Change from baseline level in joint space changes within the knee using MRI at 168 days post-injection.
Measured: From baseline to 6 months
Change from baseline of Oxford Knee Score (OKS)
Change from baseline of pain, activity, range of motion, distance…etc at 84- and 168-days post-injection using Oxford Knee Score (OKS). Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start7 Nov 2023
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellcolabs Clinical SPV Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PDC-CRO
- Responsible party
- Sponsor
- Investigators
- Fahti Yousef, PhD, Principal investigator, Cellcolabs Clinical SPV Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084988
- Sponsor's protocol ID
- 00-OA Study-2022
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06084988
- Acronym / sponsor ID
- 00-OA Study-2022
- Conditions
- Osteo Arthritis Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cellcolabs Clinical SPV LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PDC-CRO
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- 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.
This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. The main questions it aims to answer are:
To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs).
Eligible patients will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasoundguided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte
Detailed description
Osteoarthritis (OA) is a severe, chronic, and progressive disease that eventually leads to disability. OA is characterized by joint pain, stiffness, limited mobility with effusion, and inflammation. It has a negative physical and psychological impact which results in a reduced quality of life. OA occurs as an imbalance between the formation and degeneration of chondrocytes and extracellular matrix which leads to progressive destruction of articular cartilage. OA symptoms were routinely managed using pharmacologic treatments including hyaluronic acid (HA) and platelet rich plasma (PRP) injections. Recent guidelines have recommended against the use of these agents. Both treatments are mainly given for pain relief and have minimal effects on stopping the progression of OA; hyaluronic acid (HA) leads to a small reduction in knee osteoarthritis pain compared with placebo, while PRP, did not result in a significant difference in symptoms or joint structure. These findings do not support broad use of them for the treatment of knee osteoarthritis.
Mesenchymal Stromal Cells (MSCs) are one of the emerging, regenerative therapies that aim to treat, prevent and even reverse OA through their immunomodulatory properties that reduce inflammation and promote angiogenesis. MSCs are proven to regulate the body's immune response in many diseases and exert anti-inflammatory effects. These immunomodulatory properties are mediated via paracrine mechanisms. Following their discovery over 50 years ago, mesenchymal stromal cells (MSCs) have become one of the most studied cellular therapeutic products by both academia and industry due to their regenerative potential and immunomodulatory properties. The promise of MSCs as a therapeutic modality has been demonstrated in a number of preclinical data as well as in clinical setting. Stromaforte cells which will be used in this study is developed within CELLCOLABS AB and were generated following the same protocol established over the last 20 years by scientists CELLCOLABS AB at the Karolinska Institute in Sweden. MSCs showed a very promising effect in patients including vocal folds, GVHD, ARDS, multiple sclerosis and recently in patients severely infected with COVID virus.
The currently completed preclinical studies on animal models showed that intra-articular injection of MSCs can promote cartilage regeneration and reduce joint inflammation to improve the OA function of joints, and no malignant transformation of MSCs has been found as well as randomized double blinded phase I/II clinical studies reported that, the clinical manifestations, radiological and histological scores of OA patients were improved, no graft-related death, tumorigenesis and infection occurred, and no serious adverse reactions were observed. These studies demonstrated safety and tolerability of the MSCs. Based on the above results preclinical and clinical studies, it is planned to conduct this study which has been designed to evaluate the safety and tolerability of intra-articular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte in mild-to-moderate stage knee osteoarthritis patients before further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC Intervention Group | Experimental | Biological: Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)Participants will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasound-guided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. All patients will be observed for at least 2 hours post-injection at the study site. Both active monitoring and spontaneous reporting will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent and comply with all procedures required by the protocol
- Aged > 18 years at the time of signing the informed consent form
- Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis.
- Kellgren-Lawrence radiological classification scale II and III at screening
- Visual analogue scale (VAS) joint pain ≥ 2.5 at screening
Key exclusion criteria (12 listed)
- Unwilling or unable to perform any of the assessments required by the protocol
- Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
- Patients with varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs
- Patients with a history of a previous subtotal medial or lateral meniscectomy
- Patients with a history of septic arthritis in the affected joint
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 |
|---|---|---|
| Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given via ultrasound-guided intra-articular injection | Biological | MSC Intervention Group |
Primary outcome
To assess safety and tolerability within 24 hours,4 days , 28, 84 and 168 days of MSC injection
Time frame: From baseline to 6 months
To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment
10 secondary outcomes
Change from baseline in subjective pain assessment according to the VAS questionnaire 84, 168 days after treatment
Time frame: From baseline to 6 months
Change from baseline in knee-joint specific function assessed by the Knee Injury and osteoarthritis outcome score (KOOS) at 84- and 168-days post-injection
Time frame: From baseline to 6 months
Change from baseline in arthritis pain scores using the Lequesne index assessment at 84- and 168-days post treatment
Time frame: From baseline to 6 months
Change in Health-related quality of life according to Short-Form 12 at 168 days post-injection
Time frame: From baseline to 6 months
Change in TNF-alpha in synovial fluid
Time frame: From baseline to 6 months
Change in C Reactive Protein (CRP) in synovial fluid
Time frame: From baseline to 6 months
Change in Interleukin-6 (IL-6) in synovial fluid
Time frame: From baseline to 6 months
Change from baseline at levels of catabolic/anabolic products of collagens
Time frame: From baseline to 6 months
Change from baseline level in joint space changes within the knee
Time frame: From baseline to 6 months
Change from baseline of Oxford Knee Score (OKS)
Time frame: From baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
Fahti Yousef, PhD principal investigator
Cellcolabs Clinical SPV Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte) in people with Osteo Arthritis Knee, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
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 13 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: finished, as of the sponsor's last update on 16 Apr 2026. 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 United Arab Emirates. 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?
To assess safety and tolerability within 24 hours,4 days , 28, 84 and 168 days of MSC injection (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.