An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis
NCT ID: NCT05789719
Last Updated: 2023-03-29
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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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2023-11-01
2024-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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autoSTEM-OA 400
400x10\^6 autologous MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
alloSTEM-OA 400
400x10\^6 allogeneic MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
autoSTEM-OA 800
800x10\^6 autologous MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
alloSTEM-OA 800
800x10\^6 allogeneic MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
autoSTEM-OA 1600
1600x10\^6 autologous MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
alloSTEM-OA 1600
1600x10\^6 allogeneic MSC(AT)s in autologous fat
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
Interventions
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STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
Eligibility Criteria
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Inclusion Criteria
2. Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
3. Joint pain ≥ 30mm on 100mm VAS at screening
4. Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion \>1 cm in any dimension by x-ray
5. Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
6. Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
7. Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
8. Agree to donate cells to alloSTEM-OA participants.
9. Fulfils eligibility criteria for allogeneic cell- and tissue donors.
10. Speaks and reads Danish or English
Exclusion Criteria
2. Active cancer or still in follow-up (5 years)
3. Rheumatologic disease
4. Avascular disease
5. Severe bone deformity
6. Previous infection of the knee joint
7. Pes anserine bursitis
8. pain attributed to diffuse edema
9. pain attributed to displaced meniscal tear or osteochondritis
10. Neurogenic or vascular claudication
11. Bleeding disorders
12. Chemotherapy
13. Radiation therapy to the leg or adipose harvested site
14. Knee injections within 3 months of treatment
15. Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
16. Use of oral glucocorticoids.
17. Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method.
18. Known chronic disease associated with metabolism malfunction or poor healing.
19. Allergy towards necessary anaesthesia
20. Varus/valgus malalignment \>5°
21. Isolated patellofemoral arthrosis
18 Years
60 Years
ALL
No
Sponsors
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StemMedical A/S
INDUSTRY
Responsible Party
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Locations
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Sanos Clinic Syddanmark
Vejle, , Denmark
Countries
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Central Contacts
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Other Identifiers
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ST-001
Identifier Type: -
Identifier Source: org_study_id
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