HEAL AFrica Hospital The Research Center and Laboratory

Raising $750,000-$1,000,000 to conduct clinical trials and provide after care minitoring services

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Executive Summary: Combatting Tuberculosis in Africa
The Heal Africa Research Center and Laboratory for the Study of Traditional Medicines
Goma, Democratic Republic of the Congo             January 2023
The Project
Based on the extraordinary results of clinical trials conducted in 2021-2022 confirming the efficacy of Artemisia Afra as a complementary treatment for Tuberculosis, scientists in the DRC have joined with researchers in Uganda and Burundi to plan and implement Phase II clinical trials and, ultimately, product development.
 
·       The Alberta and African Great Lakes Foundation (AAGLF), in partnership with Heal Africa Hospital launched the new Research Center and Laboratory at Heal Africa Hospital, devoted to studying the efficacy of traditional medicines as complementary and potentially curative treatments of chronic diseases for African and global populations without access to vaccines and treatments. 
·       AAGLF and Heal Africa scientists and medical professionals have prioritized exploring the efficacy of Artemisia in complementing existing treatment and in potentially curing Tuberculosis, Malaria prophylaxis, Bilharzia, Diabetes, high blood pressure, Trypanosomiasis, and Buruli ulcer. 
 
The Need
TB remains one of the leading causes of death in Africa. Billions of philanthropic and government dollars globally have funded research to find a cure for TB without major breakthroughs. The number of TB cases continues to increase as multi-drug resistance TB now accounts for one-third of the world’s deaths from antimicrobial resistance
 
Scientists conducting research on traditional medicines face challenges, especially in Africa.
·       It is difficult, if not impossible, for smaller projects and more modest clinical trials to apply for and secure funding, no matter how promising a product might be. Funding for TB has been funneled to consortiums and large organizations such as the Global Fund and The Global Alliance for TB Development, which manages the largest TB drug development pipeline. The focus is on drug development partnerships (usually with big pharma groups) to locate and develop new vaccines and complementary drugs, only developed by big pharma that shorten treatment for TB and make it more affordable. Treatment solutions that are researched outside of Big Pharma, no matter the potential, are ignored, and, in all too many instances, Artemisia research has been criticized and demeaned, despite peer publications of positive outcomes. 
·       Minimal investment has been made in the research of traditional medicines, despite generations of proven homeopathic medicine and treatments. Although there has been a growing interest in traditional medicine, herbal treatments, natural product research and phytogenic drugs and phytomedicines, funding is still limited. Much of the funding awarded natural/traditional drug research focuses on optimization of active ingredients, extracts, molecular value and/or isolated herbal components.
·       Very few African Institutions receive funding for research and clinical trials, despite the serious need for effective treatments in many African nations, and the pool of extraordinary African scientists dedicated to eliminating TB. 
 
The Solutions
Conduct Phase II Clinical Trials and apply assured outcomes in developing a product for broader distribution to decrease TB infections locally, nationally and globally.
 
AAGLF and Heal Africa scientists are promoting the solutions to overcome TB infections by:
·       Partnering with Mbarara University of Science and Technology (MUST), Uganda, to implement Phase II of the Artemisia/TB study. Scheduled to begin later in 2023, Phase II trials will divide 160 patients from the DRC, Uganda and Burundi into two arms, one arm with national and WHO approved treatment alone and a second arm with the combination of national treatment and Artemisia infusion. 
·       Building traction on the success of Phase I Clinical Trials (Publication available upon request). Phase I TB trials were based on the astonishing results of smaller, preliminary trials completed in Burundi and DRC with 35 actively infected patients, who were administered Artemisia Afra infusions. All 35 patients experienced remarkably faster relief of symptoms than with conventional treatments alone. Phase I Trials, funded by private USA and European philanthropists, comprised a surveillance, one arm study with 100 patients (active TB from Goma community and prison system) to determine the anti-mycobacterial properties of Artemisia Afra and the potential for product development as a complementary TB treatment.  Trial results were astonishing: 95 of 102 patients have fully recovered (negative sputum) within the protocol time limit of 30 days. Seven patients recovered between 31 and 52 days, although they were well improved within 30 days (positive sputum).
 
Provide aftercare follow-up services for patients and their families to ensure ongoing and consistent application of Artemisia tea infusions and collecting/analyzing of data on the effectiveness of Artemisia Afra infusions for prevention of new infections.
·       Incorporating data indicating the efficacy of Artemisia tea infusion as a preventative measure for families of patients into product development. Heal Africa medical personnel continued to monitor recovered patients in the community, ensure access to artemisia tea infusions for both patients and family members, identify new infections and referrals for treatment, and provide families and inmates with information about health and wellness services. As the follow-up services progressed, it became increasingly apparent that aftercare is a crucial service, not only to ensure ongoing the health of recovered patients, but also as a potential prevention measure when patient families are informed and provided with tea infusions as well. Preliminary observations strongly suggest that comprehensive and holistic aftercare services could drive decreased infections in communities. 
·       Solicit funding to cover the costs of medical supervision and staff providing aftercare services; the Artemisia Afra cultivated by local women farmers; stipends for aftercare personnel/volunteers, who will process and distribute the tea infusions to all family members and connect families to community support; training for 10 to 15 aftercare workers on processes, procedures and chain of communication; transportation to rural areas; and a data collection system that tracks new cases and the effectiveness of prevention strategies. The aftercare program in the DRC has been designed for replication for patients in Uganda and Burundi.

 
The Product and Potential ROI
 
Global acceptance of the efficacy of Artemisia Afra’s effectiveness in combatting TB will pave the way for major research and development, branding and marketing of the tea infusion and capsule for distribution beyond local communities
 
·       Currently, small African manufacturing companies and local producers provide some communities with packaged tea and capsules and training for families to use the tea and capsules consistently to overcome (and possibly prevent) TB infections. 
·       Confirming that the tea infusions work through carefully implemented and documented Phase II Clinical Trials and monitored aftercare, accepted for peer review publication, and highlighted through media buzz, will dictate the need  for comprehensive product development, marketing and distribution and ultimately, a return on investment.
 
Risk Mitigation
 
Project leaders have focused on risk mitigation in three key areas.
·       Conducting Trials with Artemisia Afra, which grows wild in many African countries and is recognized by WHO scientists (Traditional Medicine Strategy 2014-2023 and WHO/EDM/TRM/2000.1) WHO officials acknowledge that the species Artemisia Afra grows through the southern and eastern parts of Africa and has been used in traditional medicine to treat a variety of ailments from asthma and rheumatism to malaria for more than three generations.
·       Securing all applicable approvals from government agencies to ensure professionalism and respectful acceptance of the outcomes of research. Project leaders secured approval to conduct TB clinical trials from the Congolese Pharmaceutical Regulatory Authority (ACOREP) of the Ministry of Health, the authority responsible for regulating clinical trials, as well as authorizing and controlling drug imports and exports, in the Democratic Republic of the Congo (DRC). In June 2022, the Ministry of Planning, Budget, and Investment Promotion approved the Alberta and Africa Great Lakes Foundation, manager of the TB trials (in partnership with Heal Africa Hospital), as an organization working for the interest of the Congolese population in agriculture and health sectors, worthy of funding that will ultimately benefit local communities, and enables participation in the East Africa free market initiative. Project leaders have applied for further approvals from government agencies in Uganda as well as the DRC prior to implementing Phase II Clinical Trials.
·       Securing peer reviews of protocols for the Phase I trials to ensure both compliance with international/WHO requirements and alignment with the highest standards of best clinical practice. Project leaders have published Phase I results in a peer reviewed publication.
 
Competitive Landscape
The Research Center and Laboratory at Heal Africa Hospital in the DRC has a competitive edge as the first hospital to design and dedicate resources, not only to the comprehensive and exclusive study of traditional medicines, but also to the exchange of research findings, collation of outcomes in a shared library, highlighting and showcasing of scientists and medical professionals from universities and hospitals across Africa, establishment of a collegial network among other Research Centers and Laboratories, and provision of internships and training/work study opportunities for young scientists and researchers.
Project leaders believe that it is an opportune time to launch a Research Center and Laboratory, dedicated to the study of traditional medicines in Africa and the creation of a state-of -the-art research repository. 
·       Recognizing that 60% of Africans continue to rely on traditional medicine, WHO officials developed a set of tools in and guidelines to support the scientific development of traditional medicines through the identification of their medicinal components and standardization of procedures for their use.  
ü  WHO has inspired 38 African countries to establish national programs in ministries of health dedicated to the coordination of traditional medicine activities. African institutions made progress in research and evaluation of traditional medicines; product development; and quality assurance, regulation and registration of products.  
ü  Research drew the interest of at least 34 research institutions in 26 African countries by 2018 to study priority diseases such as HIV/AIDS, SCD, diabetes and hypertension using WHO guidelines. 
ü  At least 30 states have state-registered traditional medicine products for the management of various diseases.
·       Although institutions across Africa have partnered with European and American institutions of conduct research on traditional medicines, studies are often conducted without multi-country collaboration among African nations and scientists or a shared location to catalogue and store research results. Many of the clinical trials are small, poorly funded, and often conducted in isolation without broader collegial exchange.
 
Projected Costs (Detailed budget available upon request)
 | Total Costs of Phase II Trials | DRC, Uganda and Burundi |                                   $500,000
| After care monitoring, ongoing production and distribution of prepared tea infusions, and data collection/analysis related to new infections and prevention indicators | DRC, Uganda and Burundi |                                                                                                                                         $150,000
| Panning for R&D |   |                                                                                                                        $   50,000
| Total: Trials, Aftercare, and Referral for R&D |   |                                                        $700,000-$850,000
 
Pascal Gisenya, Project Manager
1 587 974-7611
 
 
Nancy Opalack, Project Consultant
202 276-4004
 The Alberta and Africa Great Lakes Foundation
Heal Africa Hospital


About Heal Africa Hospital
 
Headed by Dr. Justin Paluku-Lussy, Heal Africa hospital has the scientific capacity to support conducting clinical studies, including a reputable laboratory, qualified personnel, and access to a sufficient number of patients. Heal Africa Hospital is a full-service training hospital in Goma, capital of North Kivu Province with a Congolese staff of 28 doctors, 54 nurses, 340+ community development advocates and educators, a small administrative team, and hundreds of Congolese volunteers. The 240-bed tertiary referral hospital is one of only three referral hospitals in the D.R.Congo. It provides general surgery, orthopedics, obstetrics and gynecology (with expertise in fistula repair), pediatrics, and internal medicine as well as established radiological and pathology services. 
 
Heal Africa provides a range of peacebuilding programs throughout North Kivu and is highly regarded as an innovative example of “peace through health”. In addition to fulfilling the traditional role of health center, Heal Africa Hospital is well-respected for its considerable medical expertise in helping the victims of conflict, rape and gender-based violence with medical, surgical care and psychosocial care. 
 
“HEAL Africa is a faith-based hospital and began with the purpose of training local doctors to address the health crisis in Congo. Over the years, the program has grown in strength and reputation, sending trained healthcare workers across DRC; and working with partners at the local and global levels. Addressing health, particularly one that takes a holistic approach in a high-need environment, is not limited to activities within the walls of the hospital. And being an “oasis” often means our hearts can be pulled in different directions as a consequence of community needs. It is a challenge that remains constant on the ground, a challenge where we humbly ask for God’s guidance and the encouraging prayers of our partners.” (Justin Paluku-Lussy, MD, Annual Report 2018)
 
Heal Africa Hospital is supported by Heal Africa, USA, a Christian nonprofit organization 501c(3) that seeks a Biblical and holistic response to the spiritual, medical, and community needs of the people in that region who have been the victims of war, poverty, instability, and violence.  
 

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