• Skip to main content

ALS Untangled™

ALSUntangled™ reviews alternative and off label treatments (AOTs), with the goal of helping people with ALS make more informed decisions about them.

  • How to Use
  • Mission & Methods
  • Completed Reviews
  • Future Reviews
  • Search
  • EnglishEnglish
    • EnglishEnglish
    • EspañolEspañol

Search ALS Untangled™

Stem cell transplants at the Hospital San Jose Tecnologico de Monterrey

Updated Review
Published: November 1, 2021
Since our review, we found a newer study of this same stem cell transplant procedure (CD133+ stem cells injected into the frontal cortex) by the same lead author (Cell Transplantation, Vol. 21, pp. 1899–1907, 2012). This was an uncontrolled case series of 67 patients with ALS who received the procedure at one of two clinics in Monterrey Mexico between June 2005 and May 2010. It is not clear whether the ten participants from the previous study we wrote about were also included in this case series. The demographics of the participants in this series are incompletely reported. For unclear reasons, adverse events were tracked for only one month after the procedure while other outcomes including survival were tracked for up to two years. Even with this very limited follow 67% of patients had adverse events and two died shortly after the procedure. Based on this data, we again do not agree with the author’s conclusion that this procedure is “safe.” The author goes on to compare the survival rates of the treated participants to the overall survival rate of all patients with ALS, concluding that the treatment “depicts a positive tendency towards disease stabilization.” We do not agree. Survival in varies widely between patients with different demographics and ALS disease characteristics. Without careful matching of these participants to any historical controls, even a gross measurement of efficacy is impossible. Of course, careful measurement of efficacy would require randomization, blinding and a concomitant control group. Our conclusion remains unchanged: there are insufficient safety or efficacy data to support stem cell transplants at the Hospital San Jose Tecnologico de Monterrey as a treatment option for ALS. More rigorous studies are needed to clarify safety and efficacy concerns.

Key Information

Click on any letter grade below for more info:
Mechanism Grade: D
Preclinical Trials Grade: U
Cases Grade: U
Trials Grade: D
Risks Grade: F
Published: Jan 2010
Download

We applaud the openness of this clinic in publishing its preliminary results. However, at the present time, there are insufficient safety or efficacy data to support stem cell transplants at the Hospital San Jose Tecnologico de Monterrey as a treatment option for ALS. Also, more rigorous studies are needed to clarify safety and efficacy concerns.

Click here to download the complete review.

Mechanistic plausibility

Grade A: Shown in a peer-reviewed publication to act on a relevant mechanism in humans

Mechanistic plausibility

Grade B: Shown in a peer-reviewed publication to act on a relevant mechanism in pre-clinical model(s)

Mechanistic plausibility - C

Grade C: Theoretically and plausibly acts on an ALS-relevant mechanism in humans

Mechanistic plausibility

Grade D: Acts on a biological mechanism but it is not clear that this mechanism is relevant in ALS

Mechanistic plausibility

Grade F: Implausible; would violate known principles or laws of biology

Mechanistic plausibility

Grade U: No useful information was found for this category

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade A: Two or more peer-reviewed publications reporting benefits in well-designed studies.

Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade B: One peer-reviewed publication reporting benefits in a well-designed study.

Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade C: One or more peer-reviewed publication(s) reporting benefits in flawed studies.

Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade D: One or more non-peer reviewed studies reporting benefits (published on a website or in an abstract)

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade F: The only studies available show no benefit

Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)

Grade U: No useful information was found for this category

Patient case reports

Grade A: One or more peer-reviewed publications reporting benefits with validated diagnosis and benefits

Patient case reports

Grade B: More than one unpublished report of benefit with validated diagnosis and benefits

Patient case reports

Grade C: One unpublished report of benefit with validated diagnosis and benefits

Patient case reports

Grade D: Subjective report(s) of benefit without validated diagnoses and/or benefits

Patient case reports

Grade F: The only reports available show no benefit

Patient case reports

Grade U: No useful information was found for this category

Patient trials

Two or more peer-reviewed publications describing benefits in well-designed randomized, blinded placebo-controlled phase III trials

Patient trials

Grade C: One or more peer-reviewed publications reporting benefits in a well-designed randomized, blinded, placebo-controlled phase I or II trial

Patient trials

Grade D: One or more peer-reviewed publications reporting benefits in a flawed trial.

Flawed trials means those in which there are identifiable problems with patient selection, randomization, blinding, controls or follow-up. These have ‘high or unclear risk of bias’ according to published criteria. Well-designed trials are those that have ‘low risk of bias’.

Patient trials

Grade F: The only trials available show no benefit

Patient trials

Grade U: No useful information was found for this category

Risks (harms that occurred on this treatment)

Grade A: No exposed patients appear to have experienced harms

Risks (harms that occurred on this treatment)

Grade B: More than 0% but less than 10% of exposed patients experienced harms (no hospitalizations or deaths)

Risks (harms that occurred on this treatment)

Grade B (oral): More than 0% but less than10% of exposed patients experienced harms (no hospitalizations or deaths)

Grade D (intravenous): More than 0% but less than 5% of exposed patients experienced death or hospitalizations

Risks (harms that occurred on this treatment)

Grade C: At least 10% of exposed patients experienced harms (no hospitalizations or deaths)

Risks (harms that occurred on this treatment)

Grade D: More than 0% but less than 5% of exposed patients experienced death or hospitalizations

Risks (harms that occurred on this treatment)

Grade D: More than 0% but less than 5% of exposed patients experienced death or hospitalizations

Grade F: At least 5% of exposed patients experienced death or hospitalization

Risks (harms that occurred on this treatment)

Grade F: At least 5% of exposed patients experienced death or hospitalization

Risks (harms that occurred on this treatment)

Grade U: No useful information was found for this category

© 2023 ALS Untangled™ · All Rights Reserved · Website by Code the Dream & Tomatillo Design