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

Osteo Arthritis Knee Clinical Trial

Official title:

An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04750252
• Other study ID #: StroMel-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 22, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Akan Biosciences, LLC
• Contact: Mukesh Kumar
• Phone: 2407504893
• Email: mkumar[@]fdamap.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• StroMel
Autologous MSC

Locations

Country	Name	City	State
United States	Mukesh	Gaithersburg	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Akan Biosciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of StroMel in subjects with moderate to severe OA of the kneee	Presence of adverse events in less than 10% of the study population. Adverse events assessed will be Grade 4 administrative site infection, Grade 3 hypersensitivity/anaphylaxis, >20% increase in WOMAC pain score, treatment-related disability, and presence of tumors post-treatment.	12 months
Primary	Overall Safety of StroMel	Summary of all study related AEs and SAEs.	12 months
Secondary	Efficacy of StroMel in managing OA of the knee	Reduction of NSAIDS, until study completion	52 weeks
Secondary	Efficacy of StroMel in assessment of OA of the knee post-treatment	Percent change from baseline in rating scales (WOMAC and VAS assessments)	52 weeks