Welcome to the NeoCartRecruitment Portfolio!This resource binder is intended to be usedby Clinical Research Specialists whenintroducing or discussing the variousrecruitment options and strategies with theclinical study staff. The contents in thisportfolio are to be used for reference onlyand should not be left at a clinical studysite or shared with potential patients. If astudy site is interested in one of the optionsavailable to them, the Clinical ResearchSpecialist will work with the clinical site topersonalize the recruitment material and toplace an order, as applicable. www.histogenics.com
Table of ContentsPatient Education / AwarenessPhysician Education / Awareness andPeer-to-Peer MaterialGeneral AdvertisingSocial MediaMulti-Media (TV, radio, video)NeoCart Contact Center InformationOther PI and Coordinator ResourcesConferences
Patient Education / AwarenessObjective: Provide additional information tophysician’s patients and potential study subjects
WebsiteNeoCartImplant.com IRB Approval Required
Patient Tri-Fold Knees hurt when you need When you experience Brochure them the most. KNEE PAIN… Damaged cartilage has Consider the NeoCart® Clinical Trial. a limited ability to repair Contact us to find out more and see you experience it every if you may qualify. step of the way. or restore itself.What you need to know about IRB Approval Requiredyour knee’s condition NeoCart Contact Center A Phase 3 clinical trial is looking for candidates withIn your joints, the ends of your bones are covered with certain knee cartilage injuries to evaluate NeoCart®,hyaline articular cartilage, a firm and durable tissue. This Call: 1-855-9-NEOCART (1-855-963-6227) an investigational cartilage tissue implantcartilage allows the bones to move smoothly over Email: [email protected] made from a patient’s own cartilage cells.one another, promoting painless mobility for joints like Study Website: www.NeoCartImplant.comyour knees. For information on the study sponsor (Histogenics), visit: www.histogenics.comHowever, this cartilage can become damaged fromathletics, traumatic injury, and normal wear and tear. To Scan this code with your smartyou, this may feel like aching, pain, swelling, locking, or phone to learn more.catching and giving way. Caution: New Biologic. Limited by Federal law to investigational use only and not available for sale.Damaged cartilage has a limited ability to repair or This FDA-regulated clinical trial’s specific criteria must be followed in determining eligibility forrestore itself. Left untreated, it might worsen and lead to inclusion. Potential participants must meet all of these criteria for inclusion. Only a doctor cana chronic condition in your knee. determine patient eligibility.
NeoCart® Take an important step with this Frequently Asked Questions important Phase 3 Clinical Trial.An implant made from your Will I be able to choose my treatment?own cells The NeoCart® Trial is being conducted in patients with certain knee cartilage injuries. This trial is intended to No. The treatment group is randomly assigned for eachNeoCart® is an investigational cartilage tissue implant to determine if NeoCart® may potentially result in durable, patient at the time of arthroscopy. Patients have a 67%treat certain knee cartilage injuries. The procedure uses long-lasting repair of certain knee cartilage injuries. chance of being treated with NeoCart® (2 out of 3) or a 33%regenerative medicine technology to create hyaline-like chance of being treated with microfracture (1 out of 3.)cartilage tissue from a patient’s own cells. All patients in this trial will receive treatment Has NeoCart® been studied in humans before?The creation and implantationof NeoCart® If you qualify and are enrolled, you will be Yes. Histogenics (the sponsor) has successfully completed1. The surgeon obtains a small, normal cartilage sample randomly selected to receive one of the following Phase 1 and Phase 2 clinical trials in patients with grade 3 chondral injury to the knee. from the patient’s knee via a minimally invasive surgical treatments: arthroscopy (knee scope) What is microfracture? NeoCart® Implant Microfracture procedure2. The sample (or biopsy) is treated and placed under 2 out of 3 1 out of 3 Microfracture is the current standard of care for severe special conditions that allow cell growth and tissue cartilage injury in the knee. Microfracture works by formation To qualify for this trial, you must: creating tiny holes, or “fractures,” in the bone underneath the injured cartilage.3. The patient’s own cells, combined with collagen / Be 18 to 55 years old (bovine-derived), form a hyaline-like cartilage Microfracture surgery does not reliably solve the tissue implant / Provide informed consent underlying problem of the injured cartilage. In most / Suffer from pain in one knee and be physician- cases, the repair tissue formed by the procedure is not4. The implant is sculpted (like a puzzle piece) to fit the the same healthy cartilage that joints need to withstand injury site in the patient’s knee diagnosed with a cartilage injury movement and bearing weight. / Be recommended by a physician for5. Through a surgical procedure called a mini- How might NeoCart be different than microfracture? arthrotomy, the NeoCart® implant is implanted in microfracture surgery the patient’s injury site and glued into place with a NeoCart® is an investigational treatment. We do not yet special adhesive All study-related surgical procedures, office visits, and know what our Phase 3 data will show. However, it may some rehabilitation costs will be paid by the trial sponsor. be different from other options because it contains the patient’s own (autologous) hyaline-like cartilage tissue. What is expected of you? Microfracture surgery and other options may stimulate Following your surgery, you will have 7-8 visits to the the growth of fibrocartilage. study physician’s office for follow-up (excluding physical training) over approximately 3 years. To learn more about What are the potential complications of NeoCart®? this trial visit www.NeoCartImplant.com. For full information on the potential risks associated with NeoCart®, please visit www.NeoCartImplant.com. How much does participation in the trial cost? Participation in the NeoCart® Trial should have minimal cost to the patient and may include the appropriate co- pay as per individual insurance coverage Patient Tri-Fold Brochure
KNEE PAINThe last thing you need is Waiting Room Poster What you might need are options. (24” x 36”) Damaged cartilage has a limited ability to repair or restore itself. A Phase 3 clinical trial is looking for candidates with certainknee cartilage injuries to evaluate NeoCart®, an investigational cartilage tissue implant made from a patient’s own cells. All study-related surgical procedures, office visits, and some rehabilitation costs will be paid by the trial sponsor.All enrolled patients receive treatment To qualify for this trial, you must: If you qualify and are enrolled, you will be / Be 18 to 55 years old randomly selected to receive one of the following / Provide informed consent surgical treatments: / Suffer from pain in one knee and be physician-diagnosed with a cartilage injury / Be recommended by a physician for microfracture surgeryNeoCart® Implant Microfracture procedure 2 out of 3 1 out of 3For more information, please visit Call: 1-855-9-NEOCART (1-855-963-6227)www.NeoCartImplant.com Email: [email protected]: New Biologic. Limited by Federal law to investigational use only and not available for sale. Scan this code with your smart phone to learn more.This FDA-regulated clinical trial’s specific criteria must be followed in determining eligibility for inclusion.Potential participants must meet all of these criteria for inclusion. Only a doctor can determine patient IRB Approval Requiredeligibility.
Patient AppointmentReminder Card Appointment Reminder Thank you for participating in The NeoCart® Clinical Trial. We appreciate your time and look forward to seeing you soon.Patient name:Visit date:Visit time:If you’re unable to attend your visit on the scheduled date,please notify us at:We appreciate your time and look forward to seeing you soon.Thanks again,Your NeoCart® Clinical Trial team IRB Approval Required
Considering microfracture? Post CardConsider the NeoCart® Phase 3 Trial (no I/E)A tissue implant to treat kneecartilage injury... Made from apatient’s own cells. Locate a site near you and learn more about NeoCart® and the company-sponsored Phase 3 clinical trial. www.NeoCartImplant.com Caution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.NeoCart Contact CenterPhone: 1-855-9-NEOCART (1-855-963-6227)Times: 8:30am – 8:00pm EST Email: [email protected] www.NeoCartImplant.com Caution: New Biologic. Limited by Federal law to www.histogenics.cominvestigational use only and is not available for sale. IRB Approval Required
Consent VideosConsent Video for Prospective Patients Coming soon IRB Approval Required
Physician Education / Awareness and Peer-to-Peer MaterialTarget Audience:Orthopedic Surgeons / Referring PhysiciansObjective: Provide information to physician'speers about the NeoCart Phase 3 trial,eligibility criteria and procedure.
Tri-Fold BrochureNeoCart(Personalized Peer-to-Peer) ® Visit the NeoCart® Website Autologous Implant to learn more. Biopsy taken if www.NeoCartImplant.com NeoCart® in Knee patient is Cartilage Repair randomized Contact the NeoCart® Contact Center to NeoCart® The NeoCart® Contact Center can helpNeoCart® Procedural Steps answer questions and provide additional information about the NeoCart® Phase 3Implant through Mini-Arthrotomy, less than 1 hour Trial, additional eligibility criteria, and help identify site locations based on geography.1. Surgical Preparation of Defect Phone: 1-855-9-NEOCART (1-855-963-6227)2. Create a Template Hours: Mon-Fri 8:30am – 8:00pm (Eastern)3. Trim Template Email: [email protected] & Fit NeoCart®4. Prepare Bioadhesive5. Apply Bioadhesive to Base6. Place NeoCart®7. Apply Bioadhesive Bradley Nelson, M.D. to Top Surface 952.806.56038. Apply Curing Agent [email protected]. Close - No sutures Considering microfracture? needed to further Consider the NeoCart® Phase 3 Trial secure the implant Caution: New Biologic. Limited by federal law toinvestigational use only and is not available for sale.
What is NeoCart®? About the Phase 3 Trial About the DataMade from a patient’s own Phase 3 Under Special Protocol Assessment Phase 1 Summary Data Resultscells, NeoCart® is aninvestigational cartilage Screening Procedure / Primary: NeoCart® showed:tissue implant to treat Randomization (N=245)Implant &certain knee cartilage Rehabilitation Dual-threshold • A favorable long-term safety profileinjuries. The proprietary Observe Endpoints Responder Analysisprocedure uses Arm 1: • Significant and sustained clinical improvement inregenerative medicine NeoCart® Knee pain/function VAS pain and IKDC Subjectivetechnology to create Implantation improvement:hyaline-like cartilage tissue from (n = 163) Phase 2 Summary Trial & Data Resultsa patient’s own cells. The NeoCart® • ≥12 pts KOOS paininvestigational study is intended to determine Arm 2: AND Purpose: Evaluate the safety and efficacy ofif NeoCart® may potentially result in durable, Microfracture NeoCart® and identify clinically meaningfullong-lasting patient response. • ≥20 pts IKDC endpoints for Phase 3 (n = 82) function Design: Baseline Year 1 Secondary: • 5-year prospective U.S. study (N=30) with a 2:1 • Time to full randomization of NeoCart to microfracture weight-bearing • Primary Endpoint: % of patients to achieve or exceed a • Failure rate: >8 point clinically meaningful improvement in both pain and deterioration in function thresholds KOOS pain at 1 year Efficacy signals:End-to-end NeoCart® Process Key Patient Eligibility Considerations • NeoCart® treated patients improved statistically6 - 9 weeks Key Inclusion significantly compared to baseline • ≥18 -55 years old;Procedure Tissue Regeneration • NeoCart® improvement was statistically significantly able & willing to give better than microfracture improvement Chondrocyte isolation, informed consent 2D cell expansion, Seeding of 3D scaffold • Knee pain and functional interruption 2 – 3 weeks indicative of Grade 3-4a focal chondral defects of the medial or lateral Dual-threshold Responder Analysis femoral condylesAssessment of Implant 100 89% NeoCart®defect & biopsy processing Key Exclusion Microfracture in bioreactor • Previous treatment of the study lesion with microfracture, 80 76% p=0.0235* 69% (joint-like Percent Responders 44% conditions) OATS or ACI (debridement allowed >3 months prior) 60 p=0.1688 (NS)** p=0.0125* 1 week • BMI >35 kg/m2 29% 40 3D static • Osteoarthritis Grade 3 or greater (Kellgren Lawrence) or 22% culture inflammatory arthritis 20 2 (up to 4) • Untreated knee instability or ACL reconstruction performed weeks <6 months prior to randomization • Meniscal insufficiency (<50% of peripheral rim remaining) 0 2 YR 3 YR 1 YR 18 9 16 7 • Malalignment of knee (>3 degrees or requiring correction) Evaluable 21 9 Caution: New Biologic. Limited by federal law to Patients: investigational use only and is not available for sale.Implantation NeoCart® harvest * Achieved statistical significance. into defect & packaging ** Small sample size may have affected ability to detect statistical significance. 5 days Crawford DC, DeBerardino, T. M., Williams, R. J. III, NeoCart®, an Autologous Cartilage Tissue Implant, Compared to Microfracture for Treatment of Distal Femoral Cartilage Lesions. An FDA Phase 2 Prospective, Randomized Clinical Trial after two Years. J Bone Joint Surg Am. 012;94:979-89. Caution: New Biologic. Limited by federal law to Tri-Fold Brochureinvestigational use only and is not available for sale. (Personalized Peer-to-Peer)
Peer-to-Peer Dinner
Dear Doctor Letter (Email Template)
Email Invitation(Peer-to-Peer)
Dear [NAME]: Dear Doctor Letter (Snail-mail Template)I am a participating investigator in a clinical trial of NeoCart®, a novel biologicimplant for patients with articular cartilage injuries in the knee. The trial is anFDA-regulated, multicenter Phase 3 trial being conducted throughout theUnited States and follows the US Phase 1 and 2 trials with published data. Thestudy, a randomized, controlled superiority trial, is evaluating NeoCartcompared to microfracture for first-line care of full-thickness chondral defects.These trials can be challenging to enroll due, in part, to the rigorousinclusion/exclusion criteria preferred by the FDA. What you might not knowis that the only cartilage product approved in the US by the FDA is Carticel.That was in 1997. Technology is more advanced now, but because of theNeocomplexities in running rigorous trials, newer technologies have not made it into our hands ®as surgeons. The onlyCart iway we will have better options for our patients is for trials like the NeoCart trial to be run to completion. As such, ICartil n Kneeam requesting your assistance. Please consider referring patients you believe might be potential candidates for thisage Repairresearch study to me for evaluation.Key criteria for enrollment include the following: • Generally healthy adult between the ages of 18 and 55 (inclusive) • Symptoms (e.g., pain, swelling, locking and dysfunction) and history consistent with Grade 3-4a focal chondral defect of the medial or lateral femoral condyle • No prior microfracture of the defect • Absence of arthritis • Stable, well-aligned knee • BMI ≤ 35 kg/m2 • Medically able to undergo arthroscopy, arthrotomy, and serial MRIs • Minimal tobacco use per weekI will also be happy to personally discuss a potential study subject with you.Thank you in advance for your assistance.Sincerely,[Investigator Name][Institution Address][Investigator Contact Phone Number]About NeoCart®NeoCart®, a Phase 3 investigational tissue implant, is produced using a patient’s own cartilage cells. A Phase 1 clinical trial conducted in theConsithe U.S. comparing NeoCart® to the standard-of-care microfracture met its endpoints for safety and for improvement in pain and function.U.S. demonstrated favorable preliminary results, which supported proceeding to a Phase 2 clinical trial. A Phase 2 clinical trial conducted indering mThe two-year results of our Phase 2 clinical trial are publicly available (Crawford et al. J Bone Joint Surg Am. 2012;94:979-89). A Phase 3 clinicalConside icrofracttrial conducted in the U.S. comparing NeoCart® to the standard-of-care microfracture is currently in progress. Information about the study isPharsteh3eTNrieaolCarture?available on http://www.NeoCartImplant.com and http://www.clinicaltrials.gov. ®
Considering microfracture? Post CardConsider the NeoCart® Phase 3 Trial (Physician Workstation) A tissue implant to treat knee cartilage injury... Made from a patient’s own cells.Locate a site near you and learn more about NeoCart® and the company-sponsored Phase 3 clinical trial. www.NeoCartImplant.com Caution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.
Post Card (Physician Workstation)Key Patient Eligibility Considerations• Able and willing to give informed consent• Between 18-55 years old• Knee pain and functional interruption indicative of Grade 3-4a focal chondral defects of the medial or lateral femoral condyles• BMI < 35 kg/m2• No significant arthritis• No ligamentous instability• No previous microfracture of the defectwww.NeoCartImplant.comPhone: 1-855-9-NEOCART (1-855-963-6227) Email: [email protected] www.histogenics.comCaution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.
Considering microfracture? Post Card - customizeConsider the NeoCart® Phase 3 Trial (Physician Workstation) A tissue implant to treat knee cartilage injury... Made from a patient’s own cells.Locate a site near you and learn more about NeoCart® and the company-sponsored Phase 3 clinical trial. www.NeoCartImplant.com Caution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.
Post Card - customize (Physician Workstation)Key Patient Eligibility Considerations• Able and willing to give informed consent• Between 18-55 years old• Knee pain and functional interruption indicative of Grade 3-4a focal chondral defects of the medial or lateral femoral condyles• BMI < 35 kg/m2• No significant arthritis• No ligamentous instability• No previous microfracture of the defectFor local referrals, please contact:Aaron Krych, M.D. Coordinator:507.284.3462 Jennifer [email protected] 507.538.3562Michael Stuart, M.D. [email protected]@mayo.eduwww.NeoCartImplant.comPhone: 1-855-9-NEOCART (1-855-963-6227) Email: [email protected] www.histogenics.comCaution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.
Poster w/ Easel (24” x 36”)
Poster with Table Easel (16” x 24”)
Sign-In SheetMD Name Title Institution Sign-InAnne Marie Black, MD System Chairman/ Eastern Ortho SpecialistsBruce Brown, MD Orthopaedic SurgeonCharles Smith, MD Mid-West OrthpaedicEileen Thomas, MD Orthopaedic SurgeonGeorge Stephanson, MD Eastern State Medicine UniversityHeather James, MD Assistant Professor -Henry Michaels, MD Orthopaedic Surgery Eastern Ortho SpecialistsJulie Morris, MDKaren Smith, MD Orthopaedic Surgeon Eastern Ortho SpecialistsKevin Lorde, MDLarry Jones, MD Orthopaedic Surgeon State University MedicineStephen Burns, MD Assistant Professor - Eastern Ortho Specialists Orthopaedic Surgery System Chairman/ Mid-West Orthpaedic Orthopaedic Surgeon Eastern State Medicine University Orthopaedic Surgeon Eastern Ortho Specialists Assistant Professor - Orthopaedic Surgery Eastern Ortho Specialists Orthopaedic Surgeon State University Medicine Orthopaedic Surgeon Assistant Professor - Orthopaedic Surgery
Name TagsAnne Marie Black, MD Bruce Brown, MDSystem Chairman / Orthopaedic Surgeon Orthopaedic Surgeon Eastern Ortho Specialists Mid-West Orthpaedic Charles Smith, MD Eileen Thomas, MDAssistant Professor - Orthopaedic Surgery Orthopaedic SurgeonEastern State Medicine University Eastern Ortho SpecialistsGeorge Stephanson, MD Heather James, MD Orthopaedic Surgeon Assistant Professor - Orthopaedic Surgery Eastern Ortho Specialists State University Medicine
Target Audience: General public – Physician’s General Advertisingin-practice patients and/or patients’ familymembers or friendsObjective: To engage physician’s patients andprospective study subjects through the variousmethods employed, i.e. brochures, posters,print, radio, and internet advertising.
Newspaper Ad The last thing you need is KNEE PAIN. What you might need are options.A Phase 3 clinical trial is looking for patients with certain knee cartilageinjuries to evaluate NeoCart®, an investigational cartilage tissue implantgrown from a patient’s own cells.All study participants will receive treatment for their knee injury —either the NeoCart® Implant (2 out of 3 chance) or microfracture procedure(1 out of 3 chance), the current standard of care.To qualify you must: If you qualify and are enrolled in this/ Be 18 to 55 years old trial, you may receive:/ Provide informed consent / The NeoCart® Implant or microfracture/ Su er from pain in one knee and be physician- procedure diagnosed with a cartilage injury / Study-related care from a study physician who/ Be recommended by a physician for specializes in knee injuries microfracture surgeryAll study-related surgical procedures, o ce visits, and some rehabilitation costs will be paid by the trial sponsor.For more information, please visit www.NeoCartImplant.comCall: 1-855-9-NEOCART (1-855-963-6227)Email: [email protected] Mark W. Hollmann, MDCaution: New Biologic. Limited by Federal law to investigational use Florida Orthopaedic Associatesonly and not available for sale. This FDA-regulated clinical trial’s speci c 740 West Plymouth Ave,criteria must be followed in determining eligibility for inclusion. Potentialparticipants must meet all of these criteria for inclusion. Only a doctor can DeLand, FL 32720determine patient eligibility. IRB Approval Required
The last thing Newspaper Ad (color) you need is KNEE PAIN. What you might need are OPTIONS.A Phase 3 clinical trial is looking for patients withcertain knee cartilage injuries to evaluate NeoCart®,an investigational cartilage tissue implant grown froma patient’s own cells.All study participants will receive treatment for theirknee injury — either the NeoCart® Implant (2 out of3 chance) or microfracture procedure (1 out of 3chance), the current standard of care.To qualify you must: If you qualify and are enrolled/ Be 18 to 55 years old in this trial, you may receive:/ Provide informed consent / The NeoCart® Implant or microfracture procedure/ Su er from pain in one knee / Study-related care from a study and be physician-diagnosed with a cartilage injury physician who specializes in knee injuries/ Be recommended by aphysician for microfracturesurgery All study-related surgical procedures, o ce visits, and some rehabilitation costs will be paid by the trial sponsor. David Palmer, MD For more information, please visit Optim Healthcare 210 East DeRenne Avenue www.NeoCartImplant.com Savannah, GA 31405 www.optimhealth.com Call: 1-855-9-NEOCART (1-855-963-6227) Kelly Wiggins, RN, CCRC Email: [email protected]@optimhealth.com Caution: New Biologic. Limited by Federal law to investigational use only 912-651-8829 and not available for sale. This FDA-regulated clinical trial’s speci c criteria must be followed in determining eligibility for inclusion. Potential participants must meet all of these criteria for inclusion. Only a doctor can determine patient eligibility. IRB Approval Required
Knee pain and swelling? Online AdCartilage damage can be caused by athletic activity and evendaily wear and tear. If you suffer from knee cartilage damage,you may be eligible to participate in a clinical study for aninvestigational treatment for certain knee cartilage injuries. Copyright © 2014 - Histogenics Sponsored by Histogenics, Corporation www.Histogenics.com To learn more, please visit our website, or call us at 1.866.9.NEOCART www.NeoCartImplant.com Caution: New Biologic. NeoCart is limited by Federal Law to investigational use only and is not available for sale. IRB Approval Required
Super Doctor AdKnee Pain Due to a CartilageInjury & Considering Microfracture? Dr. Getelman leads the knee. He is a lead investigator important research in a research trial evaluating an studying knee investigational treatment called cartilage injury. NeoCart®, a tissue implant made from a patient’s own cells, aimed atDr. Mark Getelman, a physician and repairing certain knee cartilageorthopedic surgeon at Southern injuries. He is looking for candidatesCalifornia Orthopedic Institute (SCOI), to participate in this study who arehas once again been named to Super between 18 to 55 years old and haveDoctors® for this year. His specialties symptoms of knee pain in one knee.include arthroscopic and minimally-invasive reconstructive surgery of NeoCartImplant.comthe knee and shoulder, cartilagerestoration and sports medicine. Phone: 1-855-9-NEOCART (1-855-963-6227) Hours: 8:30am – 8:00pm EST Email: [email protected]. Getelman has published articles, 818-901-6600 | www.scoi.comscienti c papers and a textbook, andhas taught advanced arthroscopic Southern California Orthopedic Institute is the preferred,surgical techniques to physicians leading expert for diagnosing and treating bone, joint, andnationwide and worldwide. Currently, muscle injuries and conditions as well as musculoskeletalhe is involved in research exploring and spinal disorders in adults and children.restorative therapies for cartilage inCaution: New Biologic. Limited by federal law to investigational use only and is not available for sale. IRB Approval Required
Banner AdsIRB Approval Required
Press Release Template IRB Approval Required
Press Release TemplateIRB Approval Required
Clinical Trial Print Advertisement (RADIO OR PRINT) Radio Advertising TemplateAre you suffering from knee pain in one of your knees caused by a cartilage injury, or have beentold by a physician that you may need microfracture surgery?You may be eligible to participate in a research study that is now being offered by an orthopedicsurgeon in X.Trial OverviewA local orthopedic surgeon is participating in a Phase 3 clinical trial to evaluate the safety andeffectiveness of an investigational cartilage tissue implant, NeoCart, compared to microfracture,for the treatment of cartilage defects of the knee.You may be eligible to participate in this trial if: • You are able and willing to give informed consent • You are between the ages of 18 and 55 years old • You have been physician-diagnosed with an isolated cartilage defect in one knee And • You have been recommended for microfracture surgery by a physicianPatients may receive compensation for their participation in this trial. Certain study-related costs will be paid by the trial sponsor for study participants who qualify for suchcoverage.If you are interested in learning more about participating in this trial, please visit the NeoCartwebsite at: http://www.NeoCartImplant.com, or contact the NeoCart Contact Center at1.855.9.NEOCART. IRB Approval Required
SMoecdiaila Social MediaObjective: To engage and foster dialogueamong individuals with knee pain as well ascreate awareness of the NeoCart Trial.
Facebook PageIRB Approval Required
Facebook AdsIRB Approval Required
Twitter PageIRB Approval Required
Twitter PostsIRB Approval Required
LinkedIn PostsIRB Approval Required
Multi-Media (TV, radio, video)Objective: Increase broad local and nationalawareness about NeoCart and the NeoCart Trial.
Procedural VideoNeoCart Procedural Video Coming soon
B-Roll VideoNeoCart B-Roll Video Coming soon
High-Impact VideosNeoCart High-Impact Videos Coming soon
Broadcast News Segment
NeoCart Contact Center InformationObjective: To provide excellent customer serviceto potential NeoCart Trial patients and facilitatethe patient screening and eligibility process.
Contact Center
NeoCart Contact Center Contact Center Phone: 1-855-9-NEOCARTHours of Operation: Mon-Fri 8:30am – 8:00pm Eastern Standard Time (EST) Email: [email protected] www.NeoCartImplant.com
Other PI and Coordinator ResourcesObjective: To provide additional educationaland support resources for physicians andstudy coordinators.
Trial Reference Card Clinical Study Clinical Study HISTOGENICS CORPORATION Protocol No. 8-01 Protocol No. 8-01 Protocol No. 8-01SCHEDULE OF ASSESSMENTS SCHEDULE OF ASSESSMENTS (continued)BASELINE ASSESSMENTS POST - OPERATIVE (continued)Pre-Op Informed Consent 3 months Weight(within 3 mo) Medical History & Knee Exam (+/- 2 weeks) IKDC Objective Knee Exam X-Ray Patient Surveys: • IKDC Subjective Knee Exam Height & Weight TRIAL REFERENCE CARD Pregnancy Test (if applicable) • KOOS Knee Survey Viral Testing (HIV, Hep B and Hep C) Lab Tests: • Metabolic Panel • VAS Pain Assessment • Hematology • SF-36 Survey • Urinalysis & Urine Chemistry Medication Use & Non-Surgical Procedures Adverse Event Documentation Study MRI (standard greyscale acceptable) IKDC Objective Knee Exam 6 months Weight HISTOGENICS Nancy Lynch IRB Approval Required Patient Surveys: • IKDC Subjective Knee Exam (+/- 4 weeks) Study MRI with T2 Image Acquisition CONTACT ph: (650) 332-4393 IKDC Objective Knee Exam [email protected] • KOOS Knee Survey Patient Surveys: • IKDC Subjective Knee Exam MONITORING For Regulatory, Monitoring or eCRF questions: • VAS Pain Assessment • KOOS Knee Survey Jeff Withrow • SF-36 Survey • VAS Pain Assessment ph: (203) 981-0038 [email protected] Medication Use & Non-Surgical Procedures • SF-36 Survey ORARTHROSCOPY Medication Use & Non-Surgical Procedures Adverse Event Documentation Robert D'Alessandro Microfracture - Control Group Only ph: (781) 547-7913 Cartilage Harvest - Test Group Only 1 year Height & Weight [email protected] Adverse Event Documentation (+/- 2 mos) Study MRI with T2 Image Acquisition IKDC Objective Knee ExamIMPLANT Annual Patient Surveys: • IKDC Subjective Knee Exam SAFETY fx: (781) 547-7940 Years 2 & 3 REPORTING [email protected] NeoCart® Implant - Test Group Only (+/- 2 mos) • KOOS Knee Survey Adverse Event Documentation • VAS Pain AssessmentPOST - OPERATIVE • SF-36 Survey RADIOGRAPHIC Tonya Caralla LAB ph: (216) 445-4054 Medication Use & Non-Surgical Procedures [email protected] Days Post Operative Assessment Adverse Event Documentation(+/- 4 days) Medication Use & Non-Surgical Procedures RECRUITMENT ph: (855) 963-6227 Adverse Event Documentation Height & Weight email: [email protected] Study MRI with T2 Image Acquisition6 weeks Lab Tests: • Metabolic Panel IKDC Objective Knee Exam WEBSITES Study: www.NeoCartImplant.com(+/- 2 wks) Patient Surveys: • IKDC Subjective Knee Exam e-Diary: www.NeoCartDiary.com • Hematology • KOOS Knee Survey • Urinalysis & Urine Chemistry • VAS Pain Assessment IKDC Objective Knee Exam • SF-36 Survey Medication Use & Non-Surgical Procedures Adverse Event Documentation Medication Use & Non-Surgical Procedures Adverse Event Documentation HISTOGENICS CORPORATION NeoCart® Trial Protocol 8-01 April 15, 2014
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