Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases
NCT ID: NCT05081921
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
192 participants
INTERVENTIONAL
2022-01-05
2024-02-20
Brief Summary
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The active substance of MesoCellA-Ortho consists of in vitro expanded autologous human adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) resuspended in carrier solution for intraarticular injections for individual patents.
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Detailed Description
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The safety and clinical outcome of the treatment will be evaluated during 6 months of followup, considering patient's subjective pain level and evaluation of the improvement of knee joint function.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MesoCellA-Ortho - treated Patients with type 2 diabetes and with obesity
The patients with osteoarthritis of knee, suffering also with type 2 diabetes and obesity (BMI \> 30) will be enrolled into this group and will be treated with MesoCellA-Ortho (single intraarticular application of 20 mln of AT-MSCs resuspended in carrier solution mixed with hyaluronic acid)
MesoCellA-Ortho administration
Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in "MesoCellA-Ortho- treated" groups.
Control Patients with type 2 diabetes and obesity
The patients with osteoarthritis of knee, suffering also with type 2 diabetes and obesity (BMI \> 30) will be enrolled into this group and will be injected with hyaluronic acid (single intraarticular application of HA)
HA administration
Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in "Control Patients" groups.
MesoCellA-Ortho - treated Patients without type 2 diabetes and with obesity
The patients with osteoarthritis of knee, suffering also with obesity (BMI \> 30), but with no type 2 diabetes will be enrolled into this group and will be treated with MesoCellA-Ortho (single intraarticular application of 20 mln of AT-MSCs resuspended in carrier solution mixed with hyaluronic acid)
MesoCellA-Ortho administration
Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in "MesoCellA-Ortho- treated" groups.
Control Patients without type 2 diabetes and with obesity
The patients with osteoarthritis of knee, suffering also with obesity (BMI \> 30), but with no type 2 diabetes will be enrolled into this group and will be injected with hyaluronic acid (single intraarticular application of HA)
HA administration
Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in "Control Patients" groups.
MesoCellA-Ortho - treated Patients without type 2 diabetes and without obesity
The patients with osteoarthritis of knee, with no obesity (BMI \< 30) nor type 2 diabetes will be enrolled into this group and will be treated with MesoCellA-Ortho (single intraarticular application of 20 mln of AT-MSCs resuspended in carrier solution mixed with hyaluronic acid)
MesoCellA-Ortho administration
Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in "MesoCellA-Ortho- treated" groups.
Control Patients without type 2 diabetes and without obesity
The patients with osteoarthritis of knee, with no obesity (BMI \< 30) nor type 2 diabetes will be enrolled into this group and will be injected with hyaluronic acid (single intraarticular application of HA)
HA administration
Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in "Control Patients" groups.
Interventions
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MesoCellA-Ortho administration
Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in "MesoCellA-Ortho- treated" groups.
HA administration
Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in "Control Patients" groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 40-70 years (inclusive)
3. No contraindications for liposuction
4. No contraindications for the general use of biological treatment, stem cells, PRP and whole autologous blood
5. Availability to take part into all study visits, barring unforeseen circumstances
6. Able and willing to perform exercises at home given by a physiotherapist
7. Contraceptive (birth control pills, injection, pessary or intrauterine device (IUD), spermicide condoms)
8. The pain intensity in treated knee not lower than grade 3 (on 11-point Numerical Rating Scale)
Exclusion Criteria
2. Pregnant or breastfeeding women.
3. Allergy or poor tolerance of hyaluronic acid.
4. Diabetes mellitus type 1, diabetes mellitus type 2 on insulin treatment.
5. Lack of medical consultation in case of patients with diabetes group.
6. Comorbidities significantly affecting overall health (e.g. history of myocardial infarction, heart failure, thrombophlebitis, arterial hypertension (hypertensive crises), chronic obstructive pulmonary disease, renal failure, liver failure, advanced atherosclerosis, psychoorganic syndrome, hemiparesis, history of stroke).
7. Current or medical history of the patient: inflammatory diseases of the joints (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative arthritis involving the spine joints, septic arthritis, prior diagnosis of target arthrosis with crystal precipitation or elevated CRP in the condition, inflammation), osteonecrosis, osteoporotic fractures or other painful joint diseases other than osteoarthritis; secondary causes of osteoarthritis (e.g. rheumatoid arthritis, fibromyalgia, birth defects).
8. Current or medical history of the patient concerning carrier state or diseases: HIV, syphilis, HBV, HCV, EBV.
9. Symptomatic sciatica with radiation of pain to the examined limb.
10. Symptomatic osteoarthritis of the hip of both limbs.
11. Significant knee injuries within 6 months such as: ligament injuries, distal femur fracture or proximal tibia fracture, arthrofibrosis or cyclops lesions.
12. Endoprosthesis of the hip or knee joints.
13. Partial / total knee or hip joints replacement planned during the study.
14. Surgical operation of the lower limbs (including arthroscopy) within 6 months before screening visit or planned during the study.
15. Constant use of orthopaedic aids.
16. Intolerance or hypersensitivity to any component of the preparation.
17. Use of alternative treatment methods i.e. acupuncture within 4 weeks before screening visit or planning their use during the study.
18. Use in the treatment of osteoarthritis:
* Hyaluronates (injections - test knee) within 3 months
* Corticosteroids (injections) within 3 months
* Oral corticosteroids within 3 months
19. If available, recent (\<14 days) blood tests results outside of the allowable ranges (e. g. morphology, electrolytes, blood clotting APTT, INR, fibrinogen, CRP, glucose) if significant for participation in clinical study, particularly regarding contraindication for liposuction procedure.
20. If available, positive results of laboratory blood tests (HIV, syphilis, HBV, HCV, CMV -IgM antibodies, mycoplasmas -IgM antibodies, toxoplasmosis IgM antibodies, EBV IgM antibodies) if significant for participation in clinical study, particularly regarding contraindication for liposuction procedure.
21. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
22. Known allergic reactions to antibiotics used in cell culture: penicillin, streptomycin, amphotericin B.
23. Intolerance or hypersensitivity to any of the anesthetics (including lignocaine).
40 Years
70 Years
ALL
No
Sponsors
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National Center for Research and Development, Poland
OTHER
KCRI
OTHER
Jagiellonian University
OTHER
Responsible Party
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Prof. Krzysztof FICEK, MD, PhD, DSc
Professor
Principal Investigators
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Krzysztof Ficek, Prof., MD, PhD, DSc
Role: PRINCIPAL_INVESTIGATOR
Galen Ortopedia Sp. z o. o
Locations
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Galen - Ortopedia Sp. Z O.O.
BieruĊ, Silesian Voivodeship, Poland
Countries
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Other Identifiers
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2019-005000-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JU-BioMiStem-01
Identifier Type: -
Identifier Source: org_study_id
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