| Eligibility |
1. Male or female ages 18-50 years.
2. Persons of childbearing potential must have a negative pregnancy test prior to
receiving the study drug and will agree to use adequate contraception (hormonal or
barrier method or abstinence) from the time of screening to a period of 2 years
following treatment. Females of childbearing potential are defined as premenopausal
and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine
pregnancy test will be performed prior to the administration of the study drug to
confirm negative results. If the urine pregnancy test is positive, the study drug will
not be administered and the result will be confirmed by a serum pregnancy test. Urine
pregnancy tests will be performed by qualified personnel using kit.
3. Persons becoming pregnant during the study will continue to be monitored for the
duration of the study or completion of the pregnancy, whichever is longer. Monitoring
will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will
be recorded.
4. Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions
ranging in size from 2 to 8 cm2. Patients with episodes of contralateral knee pain
that is asymptomatic at the time of enrollment will be eligible for inclusion.
However, as outlined in the primary study endpoints, patients with previous episodes
of contralateral knee pain who experience a repeat episode of contralateral pain
similar to their established pattern of pain during the course of the trial will not
be considered as having experienced an adverse event.
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
13. Can provide written informed consent and complete HIPAA documentation after the nature
of the study is fully explained and prior to any study-related procedure 1.2 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
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