AzTrials
AzTrials

Knee OsteoarthritisPhase 1/2NCT03869229

Adipose-derived Mesenchymal Stem Cells in Osteoarthritis

A Phase 1/2 study testing Intra-articular injection of ADMSC in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/glenohumeral joints will be enrolled according to strict inclusion and exclusion criteria. Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
Intra-articular injection of ADMSC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePoland
Study dates
5 Apr 2019to 20 Mar 2022
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • presence of osteoarthritis of the knee, hip or glenohumeral joint
  • confirmation cartilage injury, articular cartilage part or full-thickness injury by MR (Magnetic Resonance)
  • joint pain of VAS (visual analog scale score) is 1 or higher while resting, 2 and higher during any physical activity
  • loss of joint function based on scale specific for certain joints; for hip: HHS scale (Harris Hip Score), HOOS scale (Hip disability and Osteoarthritis Outcome Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC); for knee: modified HHS score (Harris Hip Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The International Knee Documentation Committee (IKDC Questionnaire) and KOOS scale (Osteoarthritis Outcome Score); glenohumeral joint: Disability of Arm, Shoulder and Hand [DASH], CONSTANT score
  • clinical indication for surgical intervention
  • no effect of pharmacotherapy according to The World Health Organization (WHO) analgesic ladder lasting at least 6 months
  • no effect of physical rehabilitation lasting at least 6 months
  • willing to participate understand and sign the consent form of this study

Who cannot join

  • active inflammatory disease or infection,
  • skin disease/infection around joint,
  • severe heart failure,
  • anemia,
  • active/history of human immunodeficiency viruses (HIV), the hepatitis B virus (HBV) or the hepatitis C virus (HCV) infection,
  • pregnant or breast-feeding women,
Show all 9Show fewer
  • mental disease, addiction to drugs or alcohol,
  • participate other clinical experiments in 6 months,
  • refuse to sign the consent form, or cannot keep follow-up visit.

Trial locations and contacts

1 site in 1 country.

Marek Postula, MD, PhD contact

+48605113346

mpostula@wum.edu.pl

Robert Śmigielski, MD, PhD contact

+48609455055

rsmigielski@gmail.com

Poland1 site, 1 recruiting

  • Life Clinic

    Warsaw, Mazovian, 00-132

    Robert Śmigielski, MD, +48609455055

    Robert Śmigielski

    Recruiting

Other trials in Poland

About this study

Official title: Effectiveness of Adipose-derived Mesenchymal Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features.

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/glenohumeral joints will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive a single dose of at least 10 million of autologous Adipose-derived Mesenchymal Stem Cells (ADMCS) every three months for 12 months (maximum four doses in total and at least 40 million of ADMCS in total) via ultrasound guided intra-articular injection.

Read the detailed description

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients will be selected and sign consent forms, then divided into 3 groups based on clinical presentation. Participants will be exposed to abdominal liposuction procedure under local anesthesia for adipose-derived mesenchymal stem cells (ADMSC) harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in the Polish Stem Cell Bank. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under ultrasound guidance at the theater under spinal anesthesia. Each patient will receive a single dose of at least 10 million of ADMSC in 3 mL of normal saline every three months for 12 months (maximum four doses in total and at least 40 million of ADMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected joint. The local and systemic safety of the procedure and therapy with ADMSC will be also determined during study.

Being tested
Intra-articular injection of ADMSC
Keywords
osteoarthritis, Adipose-derived Mesenchymal Stem Cells
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis

What participants receive

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

  • Intra-articular injection of ADMSCBiological

    Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

Study groups in NCT03869229
Study groupRoleWhat they receive
osteoarthritis of the kneeActive comparatorIntervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)
Receives: Biological: Intra-articular injection of ADMSC
osteoarthritis of the hipActive comparatorIntervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)
Receives: Biological: Intra-articular injection of ADMSC
osteoarthritis of the glenohumeral jointActive comparatorIntervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)
Receives: Biological: Intra-articular injection of ADMSC

What is being measured

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

  1. HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS)

    Change in hip disability and osteoarthritis outcome score (HOOS) score. HOOS consists of 5 subscales: pain, other symptoms, function in activities of daily living (ADL), and function in sport and recreation (Sport/Rec), and hip-related quality of life (QOL). In total, 40 items: 10 items for pain, 5 items for other symptoms (3 for symptoms and 2 for stiff- ness), 17 items for function in ADL, 4 items for function in Sport/Rec, and 4 items for hip-related QOL. Standardized answer options are given (5 Likert boxes) and each question is scored from 0 to 4. Scores are summarized for each subscale and trans- formed to a 0-100 scale (0 indicating extreme problems and 100 indicating no problems).

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  2. Harris Hip Score

    Change in Harris Hip Score (HHS) score. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  3. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Change in Knee injury and Osteoarthritis Outcome Score (KOOS). It holds 42 items in 5 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)

    The five patient-relevant subscales of KOOS are scored separately: 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). 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.

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  4. modified Harris Hip Score for knee

    Change in modified Harris Hip Score (mHHS) score. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  5. The International Knee Documentation Committee (IKDC Questionnaire)

    Change in IKDC Questionnaire score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function

    The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  6. WOMAC (for hip and knee)

    Change in WOMAC score. WOMAC score is used to assess patients with osteoarthritis of the hip or knee using 24 parameters in 5 categories.

    1 Pain 2.Stiffness 3.Physical function 4.Social function 5. Emotional function

    Scoring and Interpretation

    Response : points none - 0 slight 1 moderate 2 severe 3 extreme 4

    score = = summary (points for relevant items) average score = = (total score) / (number of items) Interpretation: minimum total score: 0 maximum total score: 96 minimum pain subscore: 0 maximum pain subscore: 20 minimum stiffness subscore: 0 maximum stiffness subscore: 8 minimum physical function subscore: 0 maximum physical function subscore: 6

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  7. Disability of Arm, Shoulder and Hand [DASH]

    Change in DASH score. DASH outcome measure is a 30-item. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items).

    The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability

    A minimum score is 30; a maximum is 150. The range of the scores, therefore-from 30 to 150-equals 120. The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  8. The Constant-Murley score (CMS)

    Change in CMS score. CMS is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient

    The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  9. Visual Analog Scale (VAS)

    Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control The VAS is a commonly used tool in health outcome studies, when using it to assess importance of certain action or intervention, how we can interpret the results, on 1 to 10 line (where 1; the least and the 10; the highest)

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

Secondary outcomes (9)

  1. Nature, incidence and severity of adverse events (AEs)

    Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.

    Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups. Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.

    Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups

    Measured: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)

  2. Change in cartilage thickness

    Cartilage thickness on MRI in mm

    Measured: Baseline, and 12 months post-treatment cycle

  3. Change in cartilage volume

    Cartilage volume on MRI in ml

    Measured: Baseline, and 12 months post-treatment cycle

  4. Change in cartilage morphology

    Cartilage morphology on MRI. Change in the International Cartilage Repair Society (ICRS) classification. It is based on grading of cartilage lesions, in which lesions are graded 0 to 4 based on depth of the lesion. Grade 1 and 2 lesions have excellent prognosis. Grade 2 and 3 lesions may benefit from cartilage debridement or other more conservative surgical measures. Grade 4 lesions extend into the subchondral bone and may require bone grafting if bony cavitation is extensive

    Measured: Baseline, and 12 months post-treatment cycle

  5. Change in subchondral bone morphology

    Subchondral bone morphology (i.e. edema) on MRI

    Measured: Baseline, and 12 months post-treatment cycle

  6. Inflammation monitoring

    Baseline, and 12 months post-treatment cycle based on changes of concentrations of interleukin (IL)-1β (pg/ml), IL-6 (pg/ml), IL-8 (pg/ml), IL-11 (pg/ml), tumor necrosis factor (TNF)-alpha (pg/ml)

    Measured: Baseline, and 12 months post-treatment cycle]

  7. Inflammation monitoring

    Baseline, and 12 months post-treatment cycle based on changes of concentrations of CD40L (ng/ml)

    Measured: Baseline, and 12 months post-treatment cycle

  8. Inflammation monitoring

    Baseline, and 12 months post-treatment cycle based on changes of high-sensitivity C-reactive protein (hsCRP ) (mg/dl)

    Measured: Baseline, and 12 months post-treatment cycle

  9. Inflammation monitoring

    Baseline, and 12 months post-treatment cycle based on changes of miRNA expression (ug/dl) defined on microarray profiling

    Measured: Baseline, and 12 months post-treatment cycle

Timeline

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

  1. First posted11 Mar 2019
  2. Study start5 Apr 2019 (estimated)
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion20 Mar 2022 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03869229
Sponsor's protocol ID
002/LIFE/2019
Status last verified
Mar 2019
First submitted
4 Mar 2019
Last updated
9 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intra-articular injection of ADMSC in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Medical University of Warsaw at 1 site in Poland.

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 8 inclusion and 9 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 9 Apr 2019. 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 Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marek Postula, MD, PhD (+48605113346, mpostula@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS) (time frame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)). The study lists 9 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 NCT03869229.

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 9 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in