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The Sickle Cell Foundation of Georgia, Inc. Clinical Trials

Northrop Grumman

The Sickle Cell Foundation of Georgia, Inc.

Since 1971, the Sickle Cell Foundation of Georgia, Inc. has stood as a bastion of hope for victims of Sickle Cell and other abnormal hemoglobin. Generous supporters, a dedicated staff, a dynamic Board, and caring volunteers make the Foundation and all of its programs and services possible. Each donation, no matter how large or small, carries a Sickle Cell patient one step further to breaking the Sickle Cell Cycle. May we have your support?

Donate to the Cannabis Clinical Trial

 

The primary objective of this campaign is to provide the funds needed to support research & protocol development of treatments via oils and any other approved delivery systems derived from Medical Marijuana (MMJ) to Sickle Cell Disease Patients.

The purpose of the human clinical trial is to research and develop protocols for the usage of medical cannabis and its derivatives to alleviate the severe pains associated with Sickle Cell Disease.

The study will determine the specific dosage needed of cannabinoids that will stay within the range of an ideal therapeutic window.

Phase 1

Sickle Cell Foundation of Georgia, Inc. (SCFG) is one of the nation’s oldest and most revered sickle cell advocacy organizations.  The primary objective of this funding campaign is to support research and protocol development of treatments via oils and any other approved delivery systems derived from Medical Cannabis to Sickle Cell Disease Patients.  The purpose of the human clinical trial is to research and develop protocols for the usage of medical cannabis and its derivatives to alleviate the severe pains associated with Sickle Cell Disease.  The study will determine the specific dosage needed for cannabinoids that will stay within the range of an ideal therapeutic window.  Staying within this specific range will ensure that patients receive the correct amount of cannabinoids that will reduce overall pain and affliction associated with this disease while keeping the patient coherent and from experiencing psychoactive effects as well as possible addiction. These same cannabinoids can also be used to ease the pains associated with chemotherapy and other diseases.

Clinical Trials Research & Protocol Development Overview

  • The objective of the trial
  • Primary and secondary end-point method of collecting data
  • Sample to be included
  • Sample size with scientific justification method of handling data
  • Statistical methods and assumptions

Statistical Sample Size Determination

Phase 1 (Local)

  • Clinical Trials on Cannabinoid Delivery System
  • 20 PATIENTS (10 MALES, 10 FEMALES; AGES 18-40)
  • Timeline 6-months

Phase 1 will demonstrate whether there is a viable platform for the performance of trials that will support the thesis regarding pain management for sickle cell patients through the use of medical cannabis.

Phase 2 (Nationwide)

  • 500 PATIENTS (250 MALES, 250 FEMALES; AGES 18-40) FDA Investigational New Drug Application (IND)

Research (Non-commercial)

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

Kendryln Pitts

 

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