ST266 Versus Standard Care In Treating Partial Thickness Burns
2019년 5월 9일 업데이트: Noveome Biotherapeutics, formerly Stemnion
Phase I/II Randomized Blinded Safety, Dose-determining Efficacy Trial Comparing Amnion-derived Cellular Cytokine Solution in 3 Different Regimens With Standard Care 0.9% Sodium Chloride in the Topical Treatment of Partial-thickness Burns
The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds.
The trial will be a prospectively randomized and double-blind trial of ST266 compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.
연구 개요
상세 설명
A Phase I/II multi-center clinical trial will be performed in 99 adults with partial-thickness burns. Two similar partial-thickness burn areas in a single patient will be selected. One burn will be randomly assigned to receive either test drug ST266 or normal saline in one of three treatment regimens.
The three treatment arms will be:
- ST266 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;
- ST266 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and
- ST266 0.01 mL/cm2 every other day vs. normal saline 0.01 mL/cm2 every other day.
Two different preclinical studies of partial-thickness burns on guinea pigs have demonstrated accelerated epithelialization with topical treatment with ST266. Similarly, preclinical studies in Yorkshire pigs have demonstrated more rapid maturity of epithelialization and better quality healing of partial-thickness skin graft donor sites with ST266 treatment.
In the preclinical studies, ST266 given in a dose of 0.01 mL/cm2 wound area appeared to saturate the wound adequately without excess and simultaneously improve healing. In preclinical toxicity studies, the dose of 0.01 mL/cm2 was shown to be safe.
연구 유형
중재적
등록 (실제)
16
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Mobile, Alabama, 미국, 36617
- University of South Alabama Dept. of Surgery
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California
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Los Angeles, California, 미국, 90033
- LAC - USC Medical Center
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Florida
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Gainesville, Florida, 미국, 32610
- Shands Burn Center at the University of Florida
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Tampa, Florida, 미국, 33606
- University of South Florida / Tampa General Hospital
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Illinois
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Kentucky
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Lexington, Kentucky, 미국, 40536-0284
- University of Kentucky Chandler Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Burn Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Missouri
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Columbia, Missouri, 미국, 65212
- University of Missouri Health Care
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Saint Louis, Missouri, 미국, 63110
- Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
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New York
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Rochester, New York, 미국, 14642
- University of Rochester
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Ohio
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Cleveland, Ohio, 미국, 44109
- MetroHealth Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15224
- Western Pennsylvania Hospital
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Texas
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Houston, Texas, 미국, 77030
- John S. Dunn Sr. Burn Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- A signed IRB (Institutional Review Board)- approved Informed Consent Form;
- 18 - 65 years of age;
- Two (2) similar, non-contiguous, partial-thickness burn wounds between 50 cm2 and 250 cm2 in area with blisters removed in a Total Body Surface Area(TBSA) burn of less than or equal to 40% TBSA;
- Burns must be thermal burns of flame or scald etiology;
- Patient must present to the burn center within 8 hours of injury;
- Normal creatinine and bilirubin levels;
- If capable of bearing children, patient must be using a medically accepted means of birth control and have a negative serum pregnancy test;
- Willing to participate in the clinical study and comply with the requirements of the trial.
Exclusion Criteria:
- The two (2) chosen wounds must not be full-thickness (extending through the dermis into the subcutaneous tissue);
- Thermal burn from chemical, electrical or radiation causes;
- Neither the study wound nor the comparator wound can be < 50 cm2 or >250 cm2 in size and cannot be on the face or hands;
- Patients with significant pulmonary injury, i.e., smoke inhalation injury requiring ventilator support;
- Patients with diabetes;
- Patients with any immune deficiency including current treatment with corticosteroid medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation therapy within 30 days of signing the informed consent;
- Abnormal bilirubin, liver function studies (i.e., Alanine transaminase (ALT); Aspartate transaminase (AST)> 2.0 times normal);
- Abnormal serum creatinine, receiving hemodialysis or peritoneal dialysis;
- Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed);
- Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
- History of non-compliance with treatment or clinical visit attendance.
- Patients whose burns were previously treated with anything other than ice, cold water or dry dressing.
- Participation in an investigational trial within 30 days of study entry.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ST266 1
Topical treatment every other day
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ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution.
Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed.
A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first.
Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
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실험적: ST266 2
Topical treatment every 4th day
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ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution.
Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed.
A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first.
Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
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실험적: ST266 3
Topical treatment every 7th day
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ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution.
Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed.
A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first.
Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary endpoint will be the percentage of each wound that has epithelialized during the 21-day treatment period comparing the ST266-treated wound with the saline-treated wound.
기간: 21 days
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21 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
기간: 21 days
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21 days
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The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
기간: 21 days
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21 days
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Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
기간: 21 days
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21 days
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Quality of healing as assessed by hemoxylin and eosin staining of the punch biopsy taken on Day 21 in the ST266-treated wounds as compared to saline-treated wounds
기간: 21 days
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21 days
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Assessment of change in arterial circulation using a laser Doppler from baseline to Day 21 in the ST266-treated wounds as compared to saline-treated wounds
기간: 21 days
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21 days
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Determination of levels of 6 cytokines present in blood prior to treatment (baseline) and within one-hour of the first treatment for the initial 12 patients
기간: 21 days
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21 days
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The primary safety endpoint will be the incidence of adverse events post-treatment.
기간: 12 months
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12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 6월 1일
기본 완료 (실제)
2010년 3월 1일
연구 완료 (실제)
2010년 3월 1일
연구 등록 날짜
최초 제출
2009년 4월 22일
QC 기준을 충족하는 최초 제출
2009년 4월 22일
처음 게시됨 (추정)
2009년 4월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 9일
마지막으로 확인됨
2019년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .