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Allogeneic bone marrow derived mesenchymal stem cells for Amputation (CHAMP Trial)
CHAMP Trial Summary
This trial will test whether injecting stem cells above and below the point of amputation can prevent ischemic wound complications and further amputations.
CHAMP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHAMP Trial Design
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Who is running the clinical trial?
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- You are taking medication to suppress your immune system for conditions like organ transplant, psoriasis, Crohn's disease, or alopecia areata.You had a heart condition called acute coronary syndrome within the past month before joining the study.You have been diagnosed with congestive heart failure (CHF) or acute coronary syndrome (ACS) according to the guidelines of the American Heart Association.You need to have a specialist determine if you need to have a major amputation on your lower extremity.You had any type of cancer, except for a type called basal cell skin carcinoma, in the past 5 years.If you have sores or tissue death, they must be located below the ankle bones to ensure there is enough space for treatment.
- Group 1: Observation Group 3
- Group 2: Control Group 4
- Group 3: Active/Treatment Group
- Group 4: Observation Group 1
- Group 5: Observation Group 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the size of the cohort participating in this trial?
"Affirmative. According to the details on clinicaltrials.gov, this medical experiment was initially advertised in January 2017 and has been actively recruiting since then with its most recent update occurring in September 2022. 16 individuals are desired for participation at a single trial site."
Are applications for this trial still being accepted?
"Affirmative. The information hosted on clinicaltrials.gov suggests that this investigation, which was originally published on the first of January 2017, is presently enrolling individuals. 16 subjects must be recruited from a single location for completion of the trial."
Is the target demographic for this experiment restricted to individuals over thirty years of age?
"To qualify for this examination, patients must be 40 to 90 years old. Of the total 1210 participants, 76 of them are younger than 18 while 1134 have already exceeded retirement age."
Who is eligible to register for the research protocol?
"This research is open to 16 individuals between 40 and 90 years old suffering from a vascular disease. Potential candidates must meet certain requirements, such as having ulceration or gangrene distal to their malleoli that allows an approximate 3cm x 10cm x 3 cm area of lower extremity for amputation (as decided by independent specialist). Additionally, the procedure can occur up to 30 days after screening. Moreover, female participants with childbearing potential are expected to utilize contraception during the course of this study; moreover they will be asked to undergo pregnancy tests at enrollment."
Has the FDA sanctioned Allogeneic bone marrow derived mesenchymal stem cells for therapeutic usage?
"The safety profile of allogeneic bone marrow derived mesenchymal stem cells was estimated at a 1, as it is only in the first phase of clinical trials and there are limited data regarding efficacy or safety."
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