An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: STEM-OA

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jesper Due Jensen, PhD; Phone Number: +45 51222087; Email: jj@stemmedical.com

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Sanos Clinic Syddanmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autoSTEM-OA 400; 400x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 400; 400x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: autoSTEM-OA 800; 800x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 800; 800x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: autoSTEM-OA 1600; 1600x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 1600; 1600x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STEM-OA safety	Number of treatment emergent adverse events (TEAEs)	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee pain	Change in KOOS 'pain' score	13 weks
Number of treatment responders	Number of treatment responders according to the OMERACT-OARSI criteria	13 weks

Collaborators and Investigators

• Sponsor: StemMedical A/S

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ST-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No