Participants in this arm undergo crestal sinus floor elevation without the use of any grafting material. The procedure involves a transcrestal (internal) sinus lift through sequential osteotomy followed by immediate placement of dental implants. The elevated sinus membrane is maintained by the implant fixture alone, allowing for natural blood clot formation and spontaneous bone regeneration.

This intervention involves a minimally invasive internal (crestal) sinus lift performed without the use of any grafting material. The sinus membrane is elevated using sequential osteotomy drills, and a dental implant is immediately placed into the prepared site. The implant fixture acts as a tent pole, maintaining the lifted membrane and allowing for spontaneous bone regeneration through blood clot formation alone. This graftless method eliminates the need for additional biomaterials and is intended for patients with residual alveolar bone height of 5-7 mm

Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement

Participants in this arm undergo crestal sinus floor elevation using platelet-rich fibrin (PRF) as the sole grafting material. PRF is prepared from the patient's own blood via centrifugation and inserted into the osteotomy site. A dental implant is then placed immediately, supporting the sinus membrane and serving as a tent for guided bone regeneration. This technique utilizes PRF's growth factors to promote healing and enhance new bone formation beneath the elevated sinus membrane.

This intervention utilizes autologous platelet-rich fibrin (PRF) as the sole grafting material during transcrestal sinus floor elevation. PRF is prepared from the patient's own venous blood using centrifugation and inserted into the osteotomy site after sinus membrane elevation. A dental implant is placed simultaneously to support the sinus membrane and stabilize the graft. The biologically active PRF matrix provides a scaffold rich in growth factors (e.g., TGF-β, PDGF, VEGF), promoting accelerated healing and enhanced bone formation beneath the elevated sinus floor. This technique is performed in a single-stage procedure, eliminating the need for synthetic or allogeneic grafts.

Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement

Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The Autologous Platelet-Rich Plasma is concentrated in a device (Angel Concentrated Platelet Rich Plasma System) to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.

Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.

Autologous Platelet-Rich Plasma

Angel Concentrated Platelet Rich Plasma System

Patients with tumors up to 4 cm can receive RT single shot of 25 Gy (or with multiple fractions with equivalent biological dose).

Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose). Patients will continue to receive the ongoing medical treatment before the randomization.

Radiotherapy + medical treatment

Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy.

Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Patients will continue to receive the ongoing medical treatment before the randomization.

Deferred Cytoreductive Nephrectomy + medical treatment

patients in the control arm continue to receive immuno-based medical treatment for mRCC.

Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.

Medical therapy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.

Tropocells(R) Autologous Platelet-Rich Fibrin

Platelet Rich Plasma

Estar Medical dba Medical Technologies, LTD

Tarek Ibraham, MBA

Lisa Standlee, FNP

Tarek Ibrahim, MBA

Liza Sanchez, FNP

Nivolumab 240 mg IV 1 q 2 weeks

OR

Nivolumab 480 mg IV 1 q 4 weeks

OR

Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID

OR

Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID

Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization

Cytoreductive Nephrectomy

Active Comparator

Continued systemic therapy as above, plus:

Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.

Site Public Contact

Arnab Basu

Chinedu Mmeje

John A. Ellerton

Benjamin R. Lee

Jay W. Carlson

Ari D. Baron

Varsha Tulpule

Abhishek Tripathi

Hyung L. Kim

Brian Shuch

Shuchi Gulati

Suthee Rapisuwon

Carlos A. Alemany

Daniel Landau

Priyank P. Patel

Adam P. Siegel

Bryan A. Faller

Joseph I. Clark

Jeffrey A. Sosman

Alan Tan

Daniel Moreira

Brian C. Myre

Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges

Vasopressor(s) will be titrated according to 56-60 range.

1- Vasopressor - Mean arterial pressure 56-60

Vasopressor(s) will be titrated according to 61-65 range.

2- Vasopressor - Mean arterial pressure 61-65

Vasopressor(s) will be titrated according to 66-70 range.

3- Vasopressor - Mean arterial pressure 66-70

Vasopressor(s) will be titrated according to 71-75 range.

4- Vasopressor - Mean arterial pressure 71-75

Thrombocytopenic intensive care unit (ICU) patients (platelet count \<50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 10 x 109/L at the time of the planned procedure.

1- Platelet less than 10 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 20 x 109/L at the time of the planned procedure.

2- Platelet less than 20 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 30 x 109/L at the time of the planned procedure.

3- Platelet less than 30 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 40 x 109/L at the time of the planned procedure.

4- Platelet less than 40 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 50 x 109/L at the time of the planned procedure.

5- Platelet less than 50 x 109/L

Tina Millen

Bram Rochwerg

Irene Watpool

Alexandre Tran

Joshua Craig

Christopher Yarnell

Jennifer Tsang

Nicole Marinoff

Neill Adhikari

Marie-Helene Masse, RRT, MSc

Julie Menard, PhD

Francois Lamontagne

Participants will receive a 6-month personalized telehealth intervention including remote patient monitoring, blood pressure management, lifestyle counseling, wearable monitoring, and multidisciplinary telemedicine visits via the Healthie platform.

Participants receive a 6 month personalized telehealth intervention via a multidisciplinary care team, delivering care via a secure digital platform, including education, risk assessment, lifestyle coaching, medical history review, and stroke risk reduction planning. The Healthie EHR is used for communication, documentation, and data integration. Syntrillo Navigators and neurology providers conduct onboarding, telemedicine visits, and coordination with patient's primary care providers and care team.

Technology-enabled Telehealth Care Plan

Participants will receive a cellular-enabled, FDA-cleared blood pressure monitor supplied by Tenovi. Blood pressure is measured twice daily during baseline and at least once daily throughout the 6-month intervention. Data is transmitted via a secure gateway to the Healthie EHR for real-time monitoring and analysis.

Blood Pressure Monitoring Device

Participants receive a connected 7-day smart pillbox that detects compartment openings and refills. Medication adherence data is uploaded in real time to a secure dashboard and integrated into the EHR.

Tenovi Smart Pillbox

Participants will utilize a commercially available wearable activity tracker to monitor step counts, resting heart rate, and heart rate variability. This data is integrated into the EHR. Devices will be provided if participants do not already own one.

Wearable Activity Trackers (Fitbit or Apple Watch)

HIPAA-compliant electronic medical record system used for participant management, secure communication, clinical documentation, and device data integration, consisting of custom workflows used for risk tracking and care planning.

Healthie EHR

Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination.

Secure Messaging Platforms (TigerConnect, Weave, AirCall)

Participants may be prescribed or have existing antihypertensive regimens adjusted (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, etc) by neurologists or nurse practitioners based on individual risk assessments and clinical findings during the study. Changed will be recorded in EHR.

Antihypertensive Medication Management

Lipid-lowering medications, including statins, may be initiated or adjusted as part of participants' care plans. Medication use is guided by cardiovascular risk and AHA guidelines. Changed will be recorded in EHR.

Statin Medication Management

Participants with atrial fibrillation or elevated cardiovascular risk may be started on or have changes to antiplatelet or anticoagulant therapy. Medication decisions are made by neurologist or nurse practitioners during telemedicine visits. Changed will be recorded in EHR.

Antiplatelet or Anticoagulant Therapy

Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.

Laboratory Blood Test Collection

The existing Baker's cyst of patients in this group will be aspirated under ultrasonographic guidance.

The existing Baker's cyst of patients in this group will be aspirated under ultrasonography guidance and PRP injection will be administered into the cyst.

PRP contains a high concentration of platelets obtained by centrifugation of autologous blood. After degranulation of platelets, various growth factors and cytokines are released and accelerate cartilage matrix synthesis, restrain synovial membrane inflammation and promote cartilage healing.

망막색소변성과 광범위 황반 위축 환자를 대상으로 자가 혈소판 풍부 혈장(PRP) 주사의 안전성과 시력 변화 효과를 살펴보는 초기 시험입니다.

Experimental: Subtenon Injection of Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4).

This arm evaluates the effect of local autologous regenerative and immunomodulatory therapy on visual function and retinal structure in patients with degenerative retinal diseases, including Retinitis Pigmentosa and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP).

Biological: Subtenon Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4).

Subtenon Injection of Autologous Platelet-Rich Plasma

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

The PRP will be prepared by drawing 60cc blood from the participant through venipuncture, spinning the blood sample in a centrifuge and then injecting the platelet rich plasma (approximately 2-5cc or max collected) into the study shoulder using ultrasound guidance. This sample will be prepared by the study provider (physician assistant or physician). Any leftover blood will be safely discarded per standard protocols.

Platelet Rich Plasma Injection

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Corticosteroid Injection

If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection.

Participants randomized to the corticosteroid injection (CSI) group who report no improvement in their pain level at the 6 week post-CSI visit will be unblinded to their study injection (CSI) and will be offered the option to stay in the study and receive Platelet Rich Plasma injection.

Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure

Walter Reed National Military Medical Center

이 시험은 남녀 탈모 환자를 대상으로 지방 유래 세포와 혈소판 농축액을 주사해 안전성과 효과를 비교하는 연구입니다.

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Intradermal injections of hair loss 3) Platelet Rich Plasma 4) Matristem Matrix (ACell)

Comparative Injection of Control (PRP \& Acel) in hair loss; 2) Intradermal Injection in hair loss

Intradermal Injection in hair loss

Growth factors and cytokines to promote healing and vascular supply

MatriStem Matrix (ACell) - Current Standard of Care

HD-PRP (High Density Platelet Rich Plasma)

1. Experimental: HD-PRP + Emulsified AD-tSVF;

   Intervention:
2. Platelet Rich Plasma
3. Adipose Derived Stem/Stromal Cells
4. Intradermal injections of hair loss

Harvesting Adipose Lipoaspirate with Microcannula System

Adipose Derived Stem/Stromal Cells

Emulsified AD-tSVF

Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF; Intervention: Intradermal injections of hair loss

1. Platelet Rich Plasma
2. Adipose Derived Stem/Stromal Cells
3. Stem/Stromal Cell Isolation
4. Intradermal injections of hair loss

Cell isolation and concentration add back to AD-stem/stromal cells utilizing Centricyte 1000 Protocol

Stem/Stromal Cellular Isolation (Digestive)

Stem/Stromal Cellular Isolate Added Back to Emulsified AD-tSVF

Emulsified AD-cSVF

대조군: 1) HD-PRP + Matristem Matrix(ACell)(현재 표준 치료법); 2) 탈모 치료제 피내 주사 3) 혈소판이 풍부한 혈장 4) Matristem Matrix(ACell)

탈모에 대한 피내 주사

혈소판이 풍부한 혈장

MatriStem Matrix(ACell) - 현재 표준 치료

HD-PRP(고밀도 혈소판 풍부 혈장)

1. 실험적: HD-PRP + 유화 AD-tSVF;

중재:
2. 혈소판 풍부 혈장
3. 지방 유래 줄기세포/기질세포
4. 탈모 치료제 피내 주사

지방유래 줄기세포/기질세포

유화 AD-tSVF

실험: HD-PRP + 유화 AD-tSVF + 유화 AD-cSVF; 중재: 탈모 부위 피내 주사

1. 혈소판 풍부 혈장
2. 지방 유래 줄기세포/기질세포
3. 줄기세포/기질세포 분리
4. 탈모 부위 피내 주사

줄기/기질 세포 분리(소화)

유화 AD-cSVF

AGA 생체세포 줄기세포/기질 모발 재생 연구

Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.

0.1-0.2 mL injections of platelet-rich plasma (PRP) will be injected to the vulvovaginal area. The injections will be placed every 5mm and at an angle of 60° into the mucosa and lamina propria of the posterior wall of the vagina.

Platelet-rich plasma (PRP)

Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months.

dual anti-platelet therapy at least 6 months

Patient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained.

dual anti-platelet therapy 3months or less

Jung-Sun Kim, MD, PhD, FESC

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Higher Platelet Transfusion Threshold

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

즉시 임플란트 식립을 동반한 무이식 경부골동저 거상술, 즉시 임플란트 식립을 동반한 혈소판 풍부 피브린(PRF) 보조 경부골동저 거상술

자가혈소판 풍부 혈장, 엔젤 농축 혈소판 풍부 혈장 시스템

지연성 세포감소성 신절제술 + 약물 치료, 방사선 치료 + 약물 치료, 약물 치료

혈소판이 풍부한 혈장

세포감소성 신절제술, 활성 비교

혈소판이 풍부한 혈장

자가 혈소판 풍부 혈장(PRP)의 결막하 주사

혈소판 풍부 혈장 주사, 코르티코스테로이드 주사, 코르티코스테로이드 주사 실패 후 지연된 혈소판 풍부 혈장 주사

AGA 생체세포 줄기세포/기질 모발 재생 연구

혈소판 풍부 혈장(PRP)

최소 6개월 이상의 이중 항혈소판 요법, 또는 3개월 이하의 이중 항혈소판 요법

혈소판 수혈 역치 상승, 혈소판 수혈 역치 하강