Is stem cell therapy legal in Colombia?
It sits in a grey area. Colombia has no regulation written specifically for stem cell or other cell treatments. The national medicines regulator, INVIMA, certifies tissue banks and labs that handle human cells and tissues under Decree 2493 of 2004 and Resolution 5108 of 2005, and clinics work under those rules.[1][2]
INVIMA set out a proposed route for regulating advanced therapies in 2017, and the Ministry of Health said specific rules would follow for cell therapies that are past the research stage.[1] No stem cell product registered for sale in Colombia was found.
What the trial record shows
INVIMA approved Colombia's first clinical trial of mesenchymal stem cells in September 2020: umbilical cord cells for patients with COVID-19 in intensive care, run by BioXcellerator in Medellín with Clínica Somer in Rionegro.[3] The trial was registered, enrolled six patients and was stopped early.[4]
Other registered studies in Colombia come from research hospitals, such as umbilical cord cells in heart surgery at Hospital San Vicente Fundación.[5]
How to check a clinic yourself
Is the clinic a licensed health provider? Search its name or tax number. Where: Ministry of Health, Registro Especial de Prestadores de Servicios de Salud (REPS).
Is the doctor registered? Search the doctor's name or ID. Where: Registro Único Nacional del Talento Humano en Salud (ReTHUS).
Which lab makes the cells? Ask for the lab's INVIMA certificate, then check it with INVIMA. Where: INVIMA.
Is there a registered study? Search by location. Where: ClinicalTrials.gov.
Questions to ask a clinic in Colombia
- Which lab makes the cells, and can I see its INVIMA certificate?
- Can I see the certificate for my batch, with the cell count and sterility tests?
- Is the clinic listed in REPS, and under what name?
- What is the treating doctor's ReTHUS registration?
- What does the price include, and what costs extra?
- Who follows me up after I fly home?
Sources
5 references
- INVIMA, Dirección de Dispositivos Médicos y Otras Tecnologías. Terapias avanzadas: una mirada desde el contexto colombiano. INVIMA, 2017. Link
- AABB. Regulatory for cellular therapies: international competent authorities, Colombia. AABB, 2026. Link
- El Colombiano. Antioquia iniciará ensayo clínico con células madre para tratar coronavirus. El Colombiano, 2020. Link
- ClinicalTrials.gov, US National Library of Medicine. NCT04390152: Wharton's jelly derived mesenchymal stem cells for ARDS due to COVID-19. 2020. Link
- ClinicalTrials.gov, US National Library of Medicine. NCT04011059: Wharton's jelly mesenchymal cells in coronary revascularisation surgery. Hospital San Vicente Fundación, 2019. Link