StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects

• Sponsor: Stratatech, a Mallinckrodt Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00618839
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 15
• Locations: 2
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This pilot Phase I/II clinical study will be conducted at up to three clinical sites.

This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.

Condition or Disease	Intervention/Treatment	Phase
Third Degree Burn; Burns; Wound Infection; Degloving Injury	Biological: StrataGraft Skin Tissue; Procedure: Cadaver allograft	Phase 1/Phase 2

Detailed Description

Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debridement and temporary wound coverage with biological dressing prior to autografting. The specific objectives of this phase I/IIa clinical trial were to assess the safety of StrataGraft skin tissue using a predetermined panel of clinical and laboratory endpoints and assess the efficacy of StrataGraft skin tissue by comparing the ability of StrataGraft skin tissue to the standard of care, human cadaver skin, to condition complex skin defects for subsequent autografting. In three cohorts of five patients each, the maximum amount of StrataGraft skin tissue applied to excised full-thickness skin wounds was increased sequentially from 0.5% to 1.0%, and then to 1.5% TBSA. Equivalent study wound areas on each subject were treated with StrataGraft or cadaver allograft for one week, at which time the allograft tissues were removed and the wound bed was evaluated. Infection and appearance of the temporary allogeneic skin tissue were evaluated at every study session until autograft placement. The wound was covered with split-thickness skin autografts when the wound was judged ready to accept an autograft. Autograft take was assessed two weeks after autograft placement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: StrataGraft : cadaver allograft All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design

Biological: StrataGraft Skin Tissue; StrataGraft™ skin tissue is provided as a suturable circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells).; Procedure: Cadaver allograft; The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.

Outcome Measures

Primary Outcome Measures

1. Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. [two weeks post-autografting]

   The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.

Secondary Outcome Measures

1. Appearance of Allograft Tissues [StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.]

   The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).

2. Viability of Allograft Tissues [At the time of allograft removal (~7 days)]

   Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged greater than 18 yrs.

• Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting

• Full-thickness skin defects

• Informed consent

Exclusion Criteria:

• Prisoners

• Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females

• Immunosuppressive therapy

• Infection with Human Immunodeficiency Virus

• Venous stasis ulcers of the lower leg

• Diabetic foot ulcers

• Donor site wounds

• Wounds of less than 5% body surface area

• Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)

• Prior entry into this study

• Expected survival of less than 3 months

• Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)

• Use of an investigational agent within 30 days

• Active malignancy

• Clinical evidence of malnutrition

• Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn & Trauma Center	Phoenix	Arizona	United States	85008
2	University of Wisconsin-Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Stratatech, a Mallinckrodt Company
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Study Director: Study Director, Stratatech, Inc., a Mallinckrodt Pharmaceeuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stratatech, a Mallinckrodt Company
• ClinicalTrials.gov Identifier: NCT00618839
• Other Study ID Numbers: STRATA2001; R44AR047499
• First Posted: Feb 20, 2008
• Last Update Posted: Oct 16, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Stratatech, a Mallinckrodt Company: Complex skin defects; Burns; Wound infection; Skin trauma
• Additional relevant MeSH terms: Wound Infection; Burns; Degloving Injuries

Study Results

Participant Flow

Recruitment Details	The study evaluated autograft take and infection in 15 patients with full-thickness skin defects who required sequential surgical procedures. Subjects had surgical excision and temporary placement of StrataGraft and cadaver allograft. The trial was conducted at the University of Wisconsin Hospital and the Arizona Burn Center.
Pre-assignment Detail	All subjects were treated with both StrataGraft and cadaver allograft in a split-wound design. The half-wound sites were randomized to receive StrataGraft or cadaver allograft.

Arm/Group Title	StrataGraft : Cadaver Allograft
Arm/Group Description	Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	StrataGraft : Cadaver Allograft
Arm/Group Description	Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.4 (14.7)
Sex: Female, Male (Count of Participants)
Female	4 26.7%
Male	11 73.3%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
Description	The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
Time Frame	two weeks post-autografting

Outcome Measure Data

Analysis Population Description

Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.

Arm/Group Title	StrataGraft Skin Tissue	Cadaver Skin
Arm/Group Description	StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.	The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
Measure Participants	15	15
Mean (Standard Deviation) [Percent Area of Autograft Take (%)]	97.7 (6.78)	96.7 (10.47)

2. Secondary Outcome

Title	Appearance of Allograft Tissues
Description	The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).
Time Frame	StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.

Outcome Measure Data

Analysis Population Description

Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.

Arm/Group Title	StrataGraft	Cadaver Skin
Arm/Group Description	StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.	The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
Measure Participants	15	15
Mean (Standard Error) [points]	1.70 (0.62)	1.49 (0.65)

3. Secondary Outcome

Title	Viability of Allograft Tissues
Description	Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.
Time Frame	At the time of allograft removal (~7 days)

Outcome Measure Data

Analysis Population Description

Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.

Arm/Group Title	StrataGraft	Cadaver Skin
Arm/Group Description	StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.	The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
Measure Participants	15	15
Median (Full Range) [Ki67 positive cells/ total cells]	0.567 (0.175)	0.189 (0.315)

Adverse Events

Arm/Group Title	StrataGraft : Cadaver Allograft
Arm/Group Description	Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
All Cause Mortality
	StrataGraft : Cadaver Allograft
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	StrataGraft : Cadaver Allograft
	Affected / at Risk (%)	# Events
Total	3/15 (20%)
General disorders
IMPAIRED HEALING	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
JOINT EFFUSION	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	StrataGraft : Cadaver Allograft
	Affected / at Risk (%)	# Events
Total	15/15 (100%)
Blood and lymphatic system disorders
ANAEMIA	3/15 (20%)	3
LEUKOCYTOSIS	1/15 (6.7%)	1
Cardiac disorders
TACHYCARDIA	1/15 (6.7%)	1
VENTRICULAR EXTRASYSTOLES	1/15 (6.7%)	1
VENTRICULAR TACHYCARDIA	1/15 (6.7%)	1
Congenital, familial and genetic disorders
MICROSTOMIA	1/15 (6.7%)	1
Eye disorders
ECTROPION	1/15 (6.7%)	1
EYE IRRITATION	1/15 (6.7%)	1
Gastrointestinal disorders
CONSTIPATION	8/15 (53.3%)	10
NAUSEA	8/15 (53.3%)	9
DIARRHOEA	7/15 (46.7%)	8
FLATULENCE	1/15 (6.7%)	1
HYPOAESTHESIA ORAL	1/15 (6.7%)	1
PRURITUS ANI	1/15 (6.7%)	1
TOOTH DISORDER	1/15 (6.7%)	1
VOMITING	3/15 (20%)	6
General disorders
ASTHENIA	3/15 (20%)	3
CHILLS	2/15 (13.3%)	3
CYST	1/15 (6.7%)	1
HYPOTHERMIA	2/15 (13.3%)	2
IMPAIRED HEALING	1/15 (6.7%)	2
OEDEMA	2/15 (13.3%)	2
OEDEMA PERIPHERAL	2/15 (13.3%)	4
PYREXIA	3/15 (20%)	5
TENDERNESS	1/15 (6.7%)	1
Immune system disorders
DRUG HYPERSENSITIVITY	1/15 (6.7%)	1
Infections and infestations
INFECTION	9/15 (60%)	13
CELLULITIS	1/15 (6.7%)	1
HERPES SIMPLEX	2/15 (13.3%)	2
PNEUMONIA	5/15 (33.3%)	5
PURULENT DISCHARGE	1/15 (6.7%)	1
SEPTIC SHOCK	1/15 (6.7%)	1
SINUSITIS	2/15 (13.3%)	2
URINARY TRACT INFECTION	1/15 (6.7%)	1
WOUND INFECTION	2/15 (13.3%)	2
Injury, poisoning and procedural complications
ESCHAR	2/15 (13.3%)	2
OPEN WOUND	1/15 (6.7%)	1
WOUND	1/15 (6.7%)	1
WOUND DEHISCENCE	1/15 (6.7%)	1
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	1/15 (6.7%)	2
ALANINE AMINOTRANSFERASE INCREASED	2/15 (13.3%)	2
ALBUMIN GLOBULIN RATIO DECREASED	1/15 (6.7%)	1
ASPARTATE AMINOTRANSFERASE DECREASED	1/15 (6.7%)	1
ASPARTATE AMINOTRANSFERASE INCREASED	4/15 (26.7%)	4
BLOOD ALBUMIN DECREASED	3/15 (20%)	3
BLOOD ALKALINE PHOSPHATASE INCREASED	4/15 (26.7%)	4
BLOOD BILIRUBIN DECREASED	3/15 (20%)	3
BLOOD BILIRUBIN INCREASED	1/15 (6.7%)	1
BLOOD CARBON DIOXIDE DECREASED	1/15 (6.7%)	1
BLOOD CHLORIDE DECREASED	1/15 (6.7%)	1
BLOOD CHLORIDE INCREASED	3/15 (20%)	3
BLOOD CREATININE DECREASED	1/15 (6.7%)	1
BLOOD CULTURE POSITIVE	3/15 (20%)	4
BLOOD LACTATE DEHYDROGENASE INCREASED	1/15 (6.7%)	1
BLOOD MAGNESIUM INCREASED	4/15 (26.7%)	4
BLOOD PHOSPHOROUS ELEVATED	1/15 (6.7%)	1
BLOOD PHOSPHORUS INCREASED	1/15 (6.7%)	1
BLOOD POTASSIUM DECREASED	1/15 (6.7%)	1
BLOOD POTASSIUM INCREASED	1/15 (6.7%)	1
BLOOD UREA DECREASED	3/15 (20%)	3
BLOOD UREA INCREASED	2/15 (13.3%)	2
C-REACTIVE PROTEIN INCREASED	1/15 (6.7%)	1
CULTURE POSITIVE	1/15 (6.7%)	1
ELEVATED PHOSPHOROUS	1/15 (6.7%)	1
GLOBULINS INCREASED	1/15 (6.7%)	1
HAEMATOCRIT DECREASED	3/15 (20%)	3
HAEMOGLOBIN DECREASED	2/15 (13.3%)	2
HIGH DENSITY LIPOPROTEIN DECREASED	1/15 (6.7%)	1
INTERNATIONAL NORMALISED RATIO INCREASED	3/15 (20%)	3
LYMPHOCYTE COUNT DECREASED	1/15 (6.7%)	1
MEAN PLATELET VOLUME DECREASED	4/15 (26.7%)	4
MONOCYTE COUNT INCREASED	1/15 (6.7%)	1
NEUTROPHIL COUNT INCREASED	2/15 (13.3%)	2
PCO2 DECREASED	1/15 (6.7%)	1
PLATELET COUNT INCREASED	8/15 (53.3%)	8
PLATELET MORPHOLOGY ABNORMAL	1/15 (6.7%)	1
PROTHROMBIN TIME PROLONGED	1/15 (6.7%)	1
RED BLOOD CELL COUNT DECREASED	2/15 (13.3%)	2
RED BLOOD CELLS URINE	1/15 (6.7%)	1
RED CELL DISTRIBUTION WIDTH INCREASED	2/15 (13.3%)	2
TRANSFERRIN DECREASED	3/15 (20%)	3
URINE OUTPUT DECREASED	1/15 (6.7%)	1
WHITE BLOOD CELL COUNT INCREASED	3/15 (20%)	3
Metabolism and nutrition disorders
ACIDOSIS	1/15 (6.7%)	1
DECREASED APPETITE	1/15 (6.7%)	2
HYPERGLYCAEMIA	1/15 (6.7%)	1
HYPERKALAEMIA	1/15 (6.7%)	1
HYPERNATRAEMIA	1/15 (6.7%)	1
HYPOCALCAEMIA	2/15 (13.3%)	2
HYPOGLYCAEMIA	5/15 (33.3%)	5
HYPOKALAEMIA	4/15 (26.7%)	5
HYPOMAGNESAEMIA	1/15 (6.7%)	1
HYPONATRAEMIA	1/15 (6.7%)	1
HYPOPHOSPHATAEMIA	1/15 (6.7%)	1
MALNUTRITION	2/15 (13.3%)	2
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/15 (6.7%)	1
EXTRASKELETAL OSSIFICATION	1/15 (6.7%)	1
JOINT EFFUSION	1/15 (6.7%)	1
LIMB DISCOMFORT	1/15 (6.7%)	1
MUSCULAR WEAKNESS	1/15 (6.7%)	1
PAIN IN EXTREMITY	1/15 (6.7%)	1
Nervous system disorders
APHONIA	1/15 (6.7%)	1
BURNING SENSATION	1/15 (6.7%)	1
COGNITIVE DISORDER	1/15 (6.7%)	1
DIZZINESS	1/15 (6.7%)	1
HYPERAESTHESIA	1/15 (6.7%)	1
HYPOAESTHESIA	2/15 (13.3%)	4
NEURALGIA	1/15 (6.7%)	1
NEUROPATHY PERIPHERAL	1/15 (6.7%)	1
PARAESTHESIA	2/15 (13.3%)	2
PERONEAL NERVE PALSY	1/15 (6.7%)	1
RADIAL NERVE PALSY	1/15 (6.7%)	2
SOMNOLENCE	1/15 (6.7%)	1
TREMOR	1/15 (6.7%)	1
Psychiatric disorders
ANXIETY	6/15 (40%)	8
INSOMNIA	8/15 (53.3%)	8
AGITATION	1/15 (6.7%)	1
CONFUSIONAL STATE	3/15 (20%)	4
DEPRESSION	2/15 (13.3%)	2
RESTLESSNESS	1/15 (6.7%)	1
Renal and urinary disorders
DYSURIA	1/15 (6.7%)	1
NOCTURIA	1/15 (6.7%)	1
RENAL FAILURE ACUTE	1/15 (6.7%)	1
URINARY RETENTION	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM	2/15 (13.3%)	3
DYSPHONIA	1/15 (6.7%)	1
NASAL CONGESTION	1/15 (6.7%)	1
PHARYNGOLARYNGEAL PAIN	2/15 (13.3%)	3
PULMONARY CONGESTION	1/15 (6.7%)	1
RESPIRATORY DISTRESS	1/15 (6.7%)	1
SLEEP APNOEA SYNDROME	1/15 (6.7%)	1
WHEEZING	1/15 (6.7%)	1
Skin and subcutaneous tissue disorders
BLISTER	2/15 (13.3%)	4
DECUBITUS ULCER	1/15 (6.7%)	1
ERYTHEMA	1/15 (6.7%)	1
HYPERHIDROSIS	1/15 (6.7%)	1
HYPERTROPHIC SCAR	1/15 (6.7%)	1
LIVEDO RETICULARIS	1/15 (6.7%)	1
PRURITUS	4/15 (26.7%)	5
RASH	4/15 (26.7%)	4
ULCER	1/15 (6.7%)	1
Surgical and medical procedures
WOUND CLOSURE	1/15 (6.7%)	1
Vascular disorders
DEEP VEIN THROMBOSIS	1/15 (6.7%)	1
HYPERTENSION	4/15 (26.7%)	4
HYPOTENSION	1/15 (6.7%)	1
ORTHOSTATIC HYPOTENSION	1/15 (6.7%)	1
POOR PERIPHERAL CIRCULATION	1/15 (6.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.