REcycled CartiLage Auto/Allo IMplantation

NCT ID: NCT03672825

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2024-06-21

Brief Summary

This is an FDA phase I study to evaluate the safety of allogeneic culture-expanded adipose-derived mesenchymal stem cells (AMSCs) combined with autologous cartilage cells to treat focal knee cartilage defects in one stage surgery.

Detailed Description

This phase I study will enroll 25 subjects with unilateral, symptomatic ICRS Grade III or IV cartilage lesions of the knee will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), radiographs, and MRI. Tissue from qualified donors will be used to establish allogeneic MSC banks (using current Good Manufacturing Practices (cGMPs) based on standard operating procedures), which will be tested and released for clinical use. Patients will undergo surgical debridement of their cartilage defect with harvest of the articular cartilage surrounding the defect rim. Following rapid digestion into chondrocytes and their pericellular matrix, autologous chondrons will be mixed in a 1:4 ratio with allogeneic AMSCs obtained from AMSC banks and suspended in fibrin glue for application to the debrided osteochondral defect. All patients will be clinically evaluated at 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 moths, and 24 months post-RECLAIM for adverse events (AEs). Following completion of their respective RECLAIM treatment, each subject will be followed-up for study endpoints using a predetermined protocol, including clinical evaluation, radiography, and MRI.

Conditions

Cartilage Defect

Study Design

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

Study Groups

RECLAIM

Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Group Type: EXPERIMENTAL

REcycled CartiLage Auto/Allo IMplantation

Intervention Type: DRUG

Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Interventions

REcycled CartiLage Auto/Allo IMplantation

Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Intervention Type: DRUG

Other Intervention Names

RECLAIM

Eligibility Criteria

Inclusion Criteria

5. Radiographic knee OA of Kellgren-Lawrence Grade 1 or less, consisting of normal knee radiographs (Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping (Grade 1)

6. Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone)

7. If applicable, at least 3 months will have passed since the last target knee intraarticular injection prior to undergoing RECLAIM therapy and at least 6 months will have passed between any prior arthroscopic or open knee procedures.

8. Able to routinely walk without assistance (e.g. cane, walker)

9. Clinically stable target knee. Patients undergoing primary anterior crucial ligament (ACL) reconstruction will be eligible for inclusion if their target knee is otherwise stable and well-aligned.

10. No additional surgery planned in the target knee for at least 12 months following RECLAIM therapy

11. Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment

12. Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments

Exclusion Criteria

To be eligible for inclusion in this study, the subjects must not meet any of the following criteria:

1. Pregnant or nursing, or planning on becoming pregnant during the study period

2. Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results

3. Significant knee malalignment that is not corrected at the time of RECLAIM surgery.

4. Injections of any kind into the target knee within 3 months prior to study enrollment

5. Greater than 50% preoperative loss in native meniscus volume (i.e. meniscectomy, degenerative loss) in the surgical knee compartment. Patients undergoing repair of meniscus tears without >50% meniscus volume loss will remain eligible for inclusion.

6. History of intra-articular infection in the target knee

7. History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee

8. History of falls requiring medical attention, or gait instability

9. Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results.

10. Body mass index (BMI) > 35 kg/m2

11. Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to surgical RECLAIM therapy

12. Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the RECLAIM treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin)

13. Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle

14. Use of electrotherapy or acupuncture for knee pain, unless there is a stable regimen for at least 4 weeks before baseline assessment

15. Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment

16. On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids

17. Current tobacco product use, including nicotine patch or other nicotine products

18. Clinically significant systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome

19. Clinically significant rheumatological or inflammatory disease of the knee or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropath

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Aaron Krych

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron J Krych

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-000939

Identifier Type: -

Identifier Source: org_study_id