Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

NCT ID: NCT04750252

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-08-31

Brief Summary

The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with moderate to severe OA of the Knee

Group Type: EXPERIMENTAL

StroMel

Intervention Type: BIOLOGICAL

Autologous MSC

Interventions

StroMel

Autologous MSC

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Adults between the ages of 25-65 years

2. Body Mass Index (BMI) less than 40 kg/m2

3. Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry.

4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days

5. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months

6. Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.

7. Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.

8. Have suitable knee joint anatomy for intra-articular injection.

9. For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion Criteria

1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.

2. Subject with an infection that requires parenteral antibiotic administration.

3. Active infection or crystal disease in the index joint within 1 month of screening

4. History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time

5. Intra-articular treatment of any joint with any of the following agents within 6 months of screening: Any corticosteroid preparation (investigational or marketed), sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection); investigational six months prior to enrollment.

6. Presence of surgical hardware or other foreign body in the index joint

7. Subjects who were administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening.

8. Planned or anticipated surgery of the joint during the study period

9. Allergies to anesthesia

10. Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests positive or reactive for CMV is not necessarily ineligible. Physicians will determine donor eligibility for subjects with positive CMV test results.

11. History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.

12. Active cancer, chemotherapy, or other malignancies in the last 6 months.

13. Recent history of DVT or pulmonary embolism requiring anticoagulants or other medicines per the hematologist.

14. Subject who participated in another clinical trial within 3 months before the screening visit

15. Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

16. Subjects who are breastfeeding

17. Subjects with uncontrolled arrhythmias

18. Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von Willebrand's disease.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akan Biosciences, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mukesh

Gaithersburg, Maryland, United States

Countries

United States

Central Contacts

Mukesh Kumar

Role: CONTACT

mkumar@fdamap.com

2407504893

Facility Contacts

Mukesh Kumar, PhD

Role: primary

mkumar@fdamap.com

2407504893

Other Identifiers

StroMel-01

Identifier Type: -

Identifier Source: org_study_id