Clinical trial
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
Name
ST-001
Description
A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat
Arms:
alloSTEM-OA 1600, alloSTEM-OA 400, alloSTEM-OA 800, autoSTEM-OA 1600, autoSTEM-OA 400, autoSTEM-OA 800
Size
20
Primary endpoint
STEM-OA safety
13 weeks
Eligibility criteria
Inclusion Criteria:
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
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:
1. Active tobacco use, or use of other nicotine substitutes
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-03-29
2 organizations
2 products
14 indications
Product
FenretinideIndication
T-cell LymphomaIndication
Cutaneous T-Cell LymphomaIndication
Peripheral T-cell LymphomaIndication
Peripheral T-Cell LymphomaIndication
Not ClassifiedIndication
Primary Cutaneous T-cell LymphomaIndication
UnspecifiedIndication
Cutaneous T-cell LymphomaIndication
Follicular T-Cell LymphomaIndication
Angioimmunoblastic T-cell LymphomaIndication
Sézary's DiseaseOrganization
Scitech DevelopmentIndication
Mycosis FungoidesOrganization
StemMedicalProduct
STEM-OAIndication
OsteoarthritisIndication
Knee